The Recall Desk
ModerateFDA (Drugs)·D-499-2013·Announced 2013-06-05

Physicians Total Care Recalls Camila Tablets Due to Impurity

Physicians Total Care is recalling specific lots of Camila 0.35 mg tablets because testing detected an impurity called N-Butyl-Benzene Sulfonamide.

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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a chemical impurity detected during testing, with no reported illnesses.

Plain-English summary

Physicians Total Care, Inc. is recalling specific lots of Camila 0.35 mg tablets. The product is distributed in 6 cards of 28 pills and was manufactured by TEVA Pharmaceuticals USA. The recall involves lots with the code 6Z4C and an expiration date of 10/31/2013.

The recall was initiated because impurity testing detected N-Butyl-Benzene Sulfonamide (NBBS) in the tablets. This finding resulted in a failure of the impurity/degradation specification. The source text does not specify the quantity of units recalled or the specific geographic distribution beyond the general context of the recall notice.

Consumers who have these specific lots of Camila tablets should stop using them and contact their healthcare provider or pharmacist for guidance. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA

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)

  • Physicians Total Care Lots: 6Z4C Exp. 10/31/2013

Distribution

Distributed in 1 state: