FDA Drug Class III — Least Serious

Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08

Hazard

Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer

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Products

Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
Brand
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
UPC
Batch 3096049

Units Affected

408 cartons

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