Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.

FDA recall notice · announced December 31, 2014 · Pharmacy Creations

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Reason for recall

Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.

Notes

Distribution: Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
Lot/code information: Lot #: 05082014@7, Exp 11/04/2014
Quantity: 67 vials
Status: Terminated
Products in this recall event:
- Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756. (D-0306-2015)
- Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756. (D-0308-2015)
- Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756. (D-0307-2015)
- Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756. (D-0305-2015)

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