FDA-Drug2014-11-12Class II

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

Physicians Total Care, Inc.
Hazard

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

Sold states
Distributed in Georgia and Missouri.
Affected count
340 capsules (17 bottles containing 20 capsules each)
Manufactured in
12515 E 55th St Ste 106, N/A, Tulsa, OK, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0237-2015

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