The Recall Desk
ModerateFDA (Drugs)·D-317-2013·Announced 2013-05-15

Physicians Total Care Recalls Plavix 75 mg Due to Moldy Odor

Physicians Total Care is recalling specific bottles of Plavix 75 mg tablets due to a chemical contamination causing an uncharacteristic moldy odor.

What this means for you

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 agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a chemical contamination (TBA) causing an odor, with no reported injuries or illnesses in the source text.

Plain-English summary

Physicians Total Care, Inc. is recalling Plavix 75 mg, 30-count bottles (NDC 54868-4070-0) manufactured by Bristol-Myers Squibb. The recall is limited to Lot # 67JV with an expiration date of 08/13.

The recall was initiated due to chemical contamination involving the presence of 2,4,6-tribromoanisole (TBA), which results in an uncharacteristic moldy odor. The source text does not specify the number of affected units or the geographic distribution of the product.

Consumers with this specific lot of Plavix should stop using the product and contact their healthcare provider or pharmacist for instructions on obtaining a replacement or refund.

The recalled product

Product
Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146.
Manufacturer
Physicians Total Care, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
60

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 (1)

  • Lot # 67JV Exp 08/13

Distribution

Distributed in 1 state:

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