Amneal Recalls Isotretinoin Capsules Due to Tretinoin Impurity Levels
Amneal Pharmaceuticals is recalling specific lots of Isotretinoin Capsules because tretinoin levels were slightly above specification limits.
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 recall as Class III, which indicates that the product is not likely to cause adverse health consequences. The deviation was a slight exceedance of specification limits for an impurity.
Plain-English summary
Amneal Pharmaceuticals, Inc. is recalling Isotretinoin Capsules, USP 10 mg. The recall involves 2,460 cartons containing 3 blister cards of 10 capsules each. The affected batch numbers are BL10917, BL11017, and BL11117, with an expiration date of 11/2019. The product is distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ.
The recall was initiated because the product failed impurities and degradation specifications, specifically because tretinoin levels were slightly above the established specification limits. The recalled product was distributed to retailers and wholesalers, who may have further distributed the product to pharmacies and other locations.
Consumers and healthcare providers should check their inventory for the specific batch numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or point of purchase for disposal or replacement in accordance with the recalling firm's instructions.
The recalled product
- Product
- ISOTRETINOIN (ISOTRETINOIN)
- Brand
- ISOTRETINOIN
- Manufacturer
- Amneal Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- 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 (4)
- Batch Numbers: BL10917
- BL11017
- BL11117
- Exp. date 11/2019
UPCs (4)
- 0369238101737
- 0369238117431
- 0369238117530
- 0369238117639
Distribution
Distribution scope not specified by the agency.
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