D-0307-2015 Class I Terminated
FDA drug recall D-0307-2015 was initiated by Pharmacy Creations on September 5, 2014 and is designated Class I. 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. The recall status is terminated (terminated July 6, 2015). Affected quantity: 52 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- December 31, 2014
- Initiation Date
- September 5, 2014
- Termination Date
- July 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52 vials
Product Description
Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
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.
Distribution Pattern
Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
Code Information
Lot #: 05202014@7, Exp 11/19/2014