Drug product
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.
D-0399-2026
Product summary
- Event
- Event 98477
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 34850 blister packs
- Official record key
drug-enforcement:D-0399-2026
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: 3116110, 3116130, Exp. Date 07/2026
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications