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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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.
- Manufacturer
- Galderma Laboratories, L.P.
- Category
- Drug — Antibiotic
- Hazard
- 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.
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