Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.

FDA recall notice · announced September 3, 2014 · Mylan Pharmaceuticals

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, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lot 3040063 Exp. 07/14
Quantity: 2,658 Bottles
Status: Terminated
Products in this recall event:
- Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05. (D-1557-2014)

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