Drug product
Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
D-0307-2015
Product summary
- Event
- Event 69184
- Status
- Terminated
- Classification
- Class I
- Quantity
- 52 vials
- Official record key
drug-enforcement:D-0307-2015
Official wording
Reason: Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Code information: Lot #: 05202014@7, Exp 11/19/2014
Distribution pattern: Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
Derived failure modes
-
Unknown
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.