Papaverine 1nj 30mg/ml

FDA recall notice · announced March 12, 2014 · Natures Pharmacy & Compounding Center

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

The product

Papaverine 1nj 30mg/ml

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Notes

Distribution: NC
Lot/code information: All lot numbers within expiry.
Status: Terminated
Products in this recall event:
- 5-Fluorouracil pf in methocel 1% opthal (D-1112-2014)
- Scopolamine 0.25 opth. (D-1132-2014)
- Pyridoxine (p-f) 100mg/ml (D-1129-2014)
- Methylcobalamin (D-1124-2014)
- Papaverine 12mg/phent 1mg/Pros 9mcq/ml (D-1127-2014)
- Ethanol 20% ophthal. (D-1110-2014)
- Dexamethasone (pf) 0.05 % opth. (D-1106-2014)
- Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic (D-1107-2014)
- Novarel (IM) (D-1125-2014)
- EDTA 3% ophthalmic (D-1111-2014)
- Bleomycin Sulfate 1unit/ml (D-1102-2014)
- Voriconazole 0.5mg/ml (D-1144-2014)
- Methotrexate Intraocular 400mcg 0.1cc (D-1123-2014)
- Tacrolimus 0.02% opth. (H20-based) (D-1135-2014)
- Vit A (olive oil) 0.1% opth. (D-1141-2014)
- Folic acid (pf) 10mg/cc inj (D-1114-2014)
- Triamcinolone Acetonide 3mg/ml (D-1139-2014)
- Tacrolimus (H20-based) 0.03% ophth. (D-1134-2014)
- Voriconazole 1% opthal (D-1143-2014)
- Cyanocobalamin 100mcg/ml injection (D-1103-2014)
- Cyano B-12 p-f 1000mcg/ml (D-1104-2014)
- Sodium Bicarbonate 8.4% inj. (D-1131-2014)
- Cyano B-12 (Cmpd) 1000mcg/ml (D-1105-2014)
- Hydroxyprogesterone Caproate (D-1121-2014)
- Tetracaine 0.5% ophth. (D-1133-2014)
- Voriconazole 0.5mg/ml (D-1145-2014)
- Lidocaine 4% Urethral Gel (D-1098-2014)
- Dexamethasone phosphate 24mg/ml inj. (D-1108-2014)
- Glutathione Inhalation 200mg/5ml (D-1119-2014)
- Testosterone Cypionate 200mg/ml (D-1138-2014)
- Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg (D-1109-2014)
- Prostaglandin all combinations (D-1128-2014)
- Bladder Instillation (D-1101-2014)
- Testosterone Cypionate 100mg/ml (D-1137-2014)
- Hydroxocobalamin inj. (D-1120-2014)
- 5-Fluorouracil 1% ophthal (D-1113-2014)
- Vancomycin (fortified) 25mg/ml opth (D-1140-2014)
- AMP/M-B12/Pyridox/Methionine Inositol (D-1100-2014)
- Vitamin D (Ergocalciferol) 800 u/ml (D-1142-2014)
- Glutathione 6%/ascorbic 1%/DMSO 6.25% (D-1117-2014)
- Renacidin Irrigation (D-1130-2014)
- L-Glutathione inhalation (D-1116-2014)
- Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25% (D-1118-2014)
- Acetylcysteine 10% ophthalmic (D-1099-2014)
- Terbutaline/Ipratropium 0.5mg/2.5ml (D-1136-2014)
- Gentamycin 80mg/1000cc 0.9% NS (D-1115-2014)
- Idoxuridine 0.1% Ophthalmic (D-1122-2014)
- Papaverine 1nj 30mg/ml (D-1126-2014)

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