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

FDA recall notice · announced November 12, 2014 · Physicians Total Care

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.

Notes

Distribution: Distributed in Georgia and Missouri.
Lot/code information: Lot Code: 79MI (Exp. Date 01/31/2015), 79SF (Exp. Date 01/31/2015), 7AH5 (Exp. Date 06/30/2015)
Quantity: 340 capsules (17 bottles containing 20 capsules each)
Status: Terminated
Products in this recall event:
- 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 Physici (D-0237-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.