PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 12, 2014 Initiated: September 22, 2014 #D-0237-2015

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.

Details

Units Affected
340 capsules (17 bottles containing 20 capsules each)
Distribution
Distributed in Georgia and Missouri.
Location
Tulsa, OK

Frequently Asked Questions

What product was recalled?
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. Recalled by Physicians Total Care, Inc.. Units affected: 340 capsules (17 bottles containing 20 capsules each).
Why was this product recalled?
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 12, 2014. Severity: Moderate. Recall number: D-0237-2015.