FDA-Drug2026-03-11Class II
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.
MYLAN PHARMACEUTICALS INC
Hazard
Failed Dissolution Specifications
Sold states
Nationwide within the United States
Affected count
34850 blister packs
Manufactured in
1311 Pineview Dr, N/A, Morgantown, WV, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0399-2026Original summary
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. Failed Dissolution Specifications Lot #: 3116110, 3116130, Exp. Date 07/2026 Distribution: Nationwide within the United States Affected quantity: 34850 blister packs
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