Drug product
Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.
D-1546-2014
Product summary
- Event
- Event 68669
- Status
- Terminated
- Classification
- Class I
- Quantity
- 70 vials
- Official record key
drug-enforcement:D-1546-2014
Official wording
Reason: Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Code information: Lot: 06062014@8, Do Not Use Beyond 12/03/2014
Distribution pattern: NY, NJ, and Puerto Rico
Derived failure modes
-
Microbial contamination
mold contamination