Recalls / Class II

Class IID-0237-2015

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

Affected lot / code info

Lot Code: 79MI (Exp. Date 01/31/2015), 79SF (Exp. Date 01/31/2015), 7AH5 (Exp. Date 06/30/2015)

Why it was recalled

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

Recalling firm

Firm

Physicians Total Care, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

12515 E 55th St Ste 106, N/A, Tulsa, Oklahoma 74146-6234

Distribution

Quantity

340 capsules (17 bottles containing 20 capsules each)

Distribution pattern

Distributed in Georgia and Missouri.

Timeline

Recall initiated

2014-09-22

FDA classified

2014-11-05

Posted by FDA

2014-11-12

Terminated

2015-03-16

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0237-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.