D-0151-2017 Class III Terminated
FDA drug recall D-0151-2017 was initiated by Mylan Pharmaceuticals Inc. on Nov 3, 2016 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: OOS results for known compound. The recall status is terminated (terminated Aug 1, 2017). Affected quantity: 51,983 extended release capsules.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 30, 2016
- Initiation Date
- Nov 3, 2016
- Termination Date
- Aug 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51,983 extended release capsules
Product description
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
Reason for recall
Failed Impurities/Degradation Specifications: OOS results for known compound.
Distribution pattern
Nationwide
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0151-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026