Drug product
Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
D-314-2016
Product summary
- Event
- Event 72241
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 prefilled syringes
- Official record key
drug-enforcement:D-314-2016
Official wording
Reason: Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Code information: Lot #: 072915, Exp 09/13/2015; 080415, Exp 09/19/2015; and 1345-081815, Exp 10/03/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility