Class III
Terminated
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
This recall has been terminated (originally issued November 30, 2016).
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- November 3, 2016
- Posted
- November 30, 2016
- Recall Number
- D-0151-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 51,983 extended release capsules
- Firm Location
- Morgantown, WV, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: OOS results for known compound.
Distribution
Nationwide
Lot / Code Info
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
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