Drug product
Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37
D-0260-2015
Product summary
- Firm
- Perry Drug Inc.
- Event
- Event 69674
- Status
- Terminated
- Classification
- Class II
- Quantity
- 186 prefilled syringes
- Official record key
drug-enforcement:D-0260-2015
Official wording
Reason: Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Code information: 141006GG, 11/6/14; 141009FF, 11/9/14; 141014BB, 11/9/14; 141014BB, 11/14/14; 1410164, 11/16/14; 141021GG, 11/21/14; 141030DD, 11/30/14
Distribution pattern: Kansas and Missouri
Derived failure modes
-
Sterility assurance
Lack of sterility