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
Reported: November 20, 2019 Initiated: October 16, 2019 #D-0321-2020
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
Reason for Recall
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Details
- Recalling Firm
- Amneal Pharmaceuticals, Inc.
- Units Affected
- 2460 cartons/3 blister cards/10 capsules each
- Distribution
- Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
- Location
- Brookhaven, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amneal Pharmaceuticals, Inc.. Units affected: 2460 cartons/3 blister cards/10 capsules each.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 20, 2019. Severity: Low. Recall number: D-0321-2020.
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