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

FDA recall notice · announced August 29, 2018 · Mylan Institutional, Inc. (d.b.a. Udl Laboratories)

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Reason for recall

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

Notes

Distribution: Nationwide USA
Lot/code information: Batch 3096049
Quantity: 408 cartons
Status: Terminated
Products in this recall event:
- 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 (D-1112-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.