Why it was recalled
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Product description
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
Lot numbers, UPCs & expiration codes
Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019
Where it was sold
Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0321-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 16, 2019
- FDA report date
- Nov 20, 2019
- Quantity
- 2460 cartons/3 blister cards/10 capsules each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0321-2020, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 84073
- Address
- 50 Horseblock Rd
- Code information
- Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019
- Postal code
- 11719-9509
- Report date
- Nov 20, 2019
- Product type
- Drugs
- Recall number
- D-0321-2020
- Classification
- Class III
- Recalling firm
- Amneal Pharmaceuticals, Inc.
- Product quantity
- 2460 cartons/3 blister cards/10 capsules each
- Termination date
- Nov 9, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
- Recall initiation date
- Oct 16, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 13, 2019