Recalls / Class III
Class IIID-0321-2020
Product
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3
- Brand name
- Isotretinoin
- Generic name
- Isotretinoin
- Active ingredient
- Isotretinoin
- Route
- Oral
- NDCs
- 69238-1017, 69238-1174, 69238-1175, 69238-1176
- FDA application
- ANDA207792
- Affected lot / code info
- Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019
Why it was recalled
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Recalling firm
- Firm
- Amneal Pharmaceuticals, Inc.
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, N/A, Brookhaven, New York 11719-9509
Distribution
- Quantity
- 2460 cartons/3 blister cards/10 capsules each
- Distribution pattern
- Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
Timeline
- Recall initiated
- 2019-10-16
- FDA classified
- 2019-11-13
- Posted by FDA
- 2019-11-20
- Terminated
- 2020-11-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0321-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.