The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0237-2015·Announced 2014-11-12

Physicians Total Care Recalls Cephalexin Capsules Due to Manufacturing Deviations

Physicians Total Care is recalling specific lots of Cephalexin Monohydrate Capsules because the active ingredients were not manufactured with good manufacturing practices.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The source cites CGMP deviations regarding the manufacturing of active ingredients but does not report specific illnesses, injuries, or fatalities, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Physicians Total Care, Inc. is recalling 340 capsules (17 bottles containing 20 capsules each) of Cephalexin Monohydrate Capsules, USP, 500 mg. The affected products are prescription-only and were distributed in Georgia and Missouri. The recall involves lot codes 79MI, 79SF, and 7AH5, all with expiration dates in 2015.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the active pharmaceutical ingredients used in these products were not manufactured in accordance with good manufacturing practices. This deviation raises concerns about the quality and consistency of the medication.

Consumers who have these specific bottles should stop using the medication and contact their healthcare provider or pharmacist for guidance. The product was manufactured for Caraco Pharmaceuticals by Sun Pharmaceuticals and repackaged by Physicians Total Care, Inc.

The recalled product

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
Manufacturer
Physicians Total Care, Inc.
Category
Drug — Antibiotic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed in 2 states:

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