Drug product
CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233
D-0237-2015
Product summary
- Event
- Event 69597
- Status
- Terminated
- Classification
- Class II
- Quantity
- 340 capsules (17 bottles containing 20 capsules each)
- Official record key
drug-enforcement:D-0237-2015
Official wording
Reason: CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Code information: Lot Code: 79MI (Exp. Date 01/31/2015), 79SF (Exp. Date 01/31/2015), 7AH5 (Exp. Date 06/30/2015)
Distribution pattern: Distributed in Georgia and Missouri.
Derived failure modes
-
Manufacturing or process control
CGMP deviations