Phentolamine mesylate 5 mg/35 mg/mannitol trituration packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

FDA recall notice · announced November 5, 2014 · Martin Avenue Pharmacy

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Notes

Distribution: Nationwide
Lot/code information: Lot Number: 04032014@14, Exp 9/30/2014; 07152014@36, Exp 1/11/2015; 07242014@21, Exp 1/20/2015
Quantity: 135.9261 gm
Status: Terminated
Products in this recall event:
- Quad mix, 9 mg/1 mg/10 mcg/0.1 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Ave (D-0130-2015)
- Hyaluronidase injection solution (PF) 150 U/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0086-2015)
- Benzalkonium chloride water for injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0063-2015)
- Hydroxyzine hydrochloride 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0094-2015)
- Voriconazole 10 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0170-2015)
- Fentanyl injectable 6000 mcg/mL packaged in 30 mLor 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0081-2015)
- Quad mix 2, 12 mg/1 mg/25 mcg/0.25 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naper (D-0127-2015)
- Quad mix, 18 mg/0.2 mg/10 mcg/0.02 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naper (D-0126-2015)
- Phenol 10% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0117-2015)
- Methylcobalamin 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0101-2015)
- Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0070-2015)
- Tri-mix T50, 8.825 mg/0.29 mg/2.95 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL (D-0167-2015)
- Vancomycin 50 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0169-2015)
- Tri-mix ST2, 30 mg/3 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0156-2015)
- Rescue solution with triamcinolone (lidocaine, bupivacaine, heparin, triamcinolone) injection solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, (D-0131-2015)
- Atropine sulfate 0.01% opthalmic solution packaged in a squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0058-2015)
- Histamine 0.55 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0083-2015)
- Methylcobalamin 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0098-2015)
- Dexamethasone sodium phosphate 4 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0076-2015)
- Opthalmic ointment base ointment packaged in a white ointment tube, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0108-2015)
- Hydromorphone HCl (PF) 1 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0090-2015)
- Sodium tetradecyl sulfate 3% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.. (D-0135-2015)
- Atropine sulfate 2 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0061-2015)
- Methylcobalamin (PF) 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0099-2015)
- Tri-mix, 30 mg/1 mg/20 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0149-2015)
- Tri-mix ST9-B, 30 mg/2 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0159-2015)
- Phenylephrine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0120-2015)
- Quad mix, 30 mg/1 mg/10 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0128-2015)
- Morphine sulfate (PF) 3 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0104-2015)
- Hydromorphone HCl/bupivacaine (PF) 10 mg/7.5 mg/mL injection packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0091-2015)
- Sodium tetradecyl sulfate 5% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0136-2015)
- Lidocaine (PF) 1% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0096-2015)
- Quad mix, 30 mg/1 mg/20 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Napervi (D-0129-2015)
- Alprostadil alcohol 500 mcg/mL injectable packaged in amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0057-2015)
- Lidocaine 1% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0095-2015)
- Tri-mix ST1, 30 mg/1.5 mg/50 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0155-2015)
- Phenylephrine 1% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0119-2015)
- Sodium tetradecyl sulfate 1% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0133-2015)
- Tacrolimus oil 0.03% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0137-2015)
- Tetracycline 250 mg powder kits packaged with powder and water in separate amber glass vials, with filter, in bag, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0141-2015)
- Testosterone cypionate 250 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0138-2015)
- Tri-mix, 30 mg/3 mg/5 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0152-2015)
- PGE 20 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0116-2015)
- Chorionic gonadotropin buffered diluent solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0069-2015)
- Hydrochloric acid/water for injection 10% (w/v) packaged in an amber glass dropper bottle, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0087-2015)
- Cyclosporine suspending vehicle packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0074-2015)
- Sodium tetradecyl SO4 stock solution 6% solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0132-2015)
- Morphine sulfate (PF) 20 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0103-2015)
- Testosterone cypionate 200 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0140-2015)
- Tri-mix T108, 30 mg/1.5 mg/25 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0165-2015)
- Tobramycin (PF) 15 mg/mL opthalmic solution packaged in opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0142-2015)
- PGE 3, 200 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0114-2015)
- Tri-mix T105, 30 mg/1 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0163-2015)
- Atropine sulfate 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0060-2015)
- Acetylcysteine 10% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0054-2015)
- Tri-mix ST5, 30 mg/1.5 mg/300 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0157-2015)
- Hyaluronidase base vehicle (PF) solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0085-2015)
- Fentanyl injectable 2000 mcg/mL packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0080-2015)
- Tri-mix SEST 4, 30 mg/1.5 mg/400 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0154-2015)
- "NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL (phentolamine mesylate, papaverine, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Napervil (D-0107-2015)
- Tri-mix ST9-E, 30 mg/4 mg/150 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0160-2015)
- Triamcinolone acetonide suspending vehicle (PF) vehicle packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0144-2015)
- Tri-mix 8.3 low dose, 22 mg/0.83 mg/8.3 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Napervill (D-0153-2015)
- Testosterone cypionate 150 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0139-2015)
- Tri-mix T101, 17.65 mg/0.59 mg/5.9 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL (D-0161-2015)
- Methylcobalamin 10 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0100-2015)
- Morphine/bupivacaine 5 mg/2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0105-2015)
- Vancomycin 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0168-2015)
- Methylcobalamin (PF) 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0102-2015)
- PGE 4, 300 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0115-2015)
- Cromolyn sodium 1% inhalant solution packaged in a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0071-2015)
- Hydroxocobalamin 10 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0093-2015)
- Hydromorphone/clonidine/bupivacaine 12 mg/600 mcg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0088-2015)
- PGE 2.5, 150 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0113-2015)
- Atropine sulfate 0.5% opthalmic solution packaged in a squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0059-2015)
- Glycerin 72% (w/v) sodium chloride injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0082-2015)
- Peng/proc/strep/chlor/hyos (penicillin G, procaine, streptomycin sulfate, chlorpheniramine maleate, hyoscyamine sulfate) (vet) injection suspension packaged in an amber glass injectable vial, Martin A (D-0110-2015)
- Tri-mix T102, 17.65 mg/0.59 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0162-2015)
- Dexamethasone sodium phosphate 24 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0077-2015)
- Paraben water for injection packaged in a sterile 1000 mL clear bottle, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0109-2015)
- Tri-mix, 30 mg/0.5 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0148-2015)
- Acetylcysteine 20% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0055-2015)
- Polyhexamethylene biguanide 2% stock solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0123-2015)
- Trimethoprim/sulfadiazine excipient stock solution injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0145-2015)
- Quad mix 1, 12 mg/1 mg/10 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naper (D-0125-2015)
- Polyhexamethylene biguanide 0.02% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. (D-0122-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.