The Recall Desk
LowFDA (Drugs)·D-1031-2016·Announced 2016-06-22

Galderma Recalls Doxycycline Capsules Due to Missing Lot and Expiration Dates

Galderma Laboratories is recalling Doxycycline USP Capsules 40 mg because some bottles are missing lot numbers or expiration dates.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling defect (missing lot/expiry) rather than a direct safety hazard like contamination or misbranding of active ingredients.

Plain-English summary

Galderma Laboratories, L.P. is recalling Doxycycline, USP Capsules 40 mg, packaged in 30-count bottles. The product is marketed by Prasco Laboratories and manufactured by Catalent Pharma Solutions, LLC. The recall involves 71,340 bottles distributed nationwide in the United States.

The recall was initiated due to labeling errors where some bottles are missing lot numbers and/or expiration dates. The affected lots are 1496059A (expiring 08/31/2017) and AD9848A (expiring 11/30/2017). The FDA has classified this as a Class III recall.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance. The recall is limited to the specific lot numbers and expiration dates listed above.

The recalled product

Product
Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
Affected units
71,340

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 (4)

  • Lot #: 1496059A
  • Expiry: 08/31/2017
  • Lot #: AD9848A
  • Expiry: 11/30/2017

Distribution

Distributed nationwide across the United States.

Same manufacturer · Galderma Laboratories, L.P.

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