Drug product
Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
D-0151-2017
Product summary
- Event
- Event 75634
- Status
- Terminated
- Classification
- Class III
- Quantity
- 51,983 extended release capsules
- Official record key
drug-enforcement:D-0151-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: OOS results for known compound.
Code information: 0378-5220-01 Lot# 3065133; Exp. 03/17 0378-5220-01 Lot# 3066564; Exp. 05/17 0378-5220-05 Lot# 3066564; Exp. 05/17 0378-5220-01 Lot# 3069645; Exp. 08/17 0378-5220-05 Lot# 3069645; Exp. 08/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications