Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.

FDA recall notice · announced July 23, 2014 · 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, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.

Reason for recall

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

Notes

Distribution: Nationwide, Puerto Rico, and Guam.
Lot/code information: Lot #: 3045659, 3048256, Exp 07/14
Quantity: 1,184 cartons
Status: Terminated
Products in this recall event:
- Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-9 (D-1435-2014)

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