D-0237-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 12, 2014
- Initiation Date
- September 22, 2014
- Termination Date
- March 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 340 capsules (17 bottles containing 20 capsules each)
Product Description
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
Reason for Recall
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Distribution Pattern
Distributed in Georgia and Missouri.
Code Information
Lot Code: 79MI (Exp. Date 01/31/2015), 79SF (Exp. Date 01/31/2015), 7AH5 (Exp. Date 06/30/2015)