FDAApril 1, 2022drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.

What to do

FDA enforcement status: Terminated

Brands named

mylan institutional inc d b a udl laboratoriesmylanmylan institutional

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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