Isotretinoin Capsules recall: Impurity Out of Spec
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
Why was Isotretinoin Capsules recalled?
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019
- 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
- Recalling firm
- Amneal Pharmaceuticals, Inc.
- Quantity
- 2460 cartons/3 blister cards/10 capsules each
- Distribution
- Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
- Recall date
- November 20, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)