FDARecalled Mar 11, 2026 · #D-0399-2026
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...
Hazard
Class II — temporary health risk
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Failed Dissolution Specifications Classification: Class II Distribution: Nationwide within the United States
Product details
- 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.
- Type
- Drugs
- Manufacturer
- MYLAN PHARMACEUTICALS INC
- Model numbers
- 3116110
- UPCs
- —