FDA-Drug2022-05-18Class II
Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Hazard
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Sold states
Nationwide within USA
Affected count
555 cartons
Manufactured in
1718 Northrock Ct, N/A, Rockford, IL, United States
Products
Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0860-2022Don't want to check this manually?
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