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
Reported: November 30, 2016 Initiated: November 3, 2016 #D-0151-2017
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.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 51,983 extended release capsules
- Distribution
- Nationwide
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 51,983 extended release capsules.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: OOS results for known compound.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 30, 2016. Severity: Low. Recall number: D-0151-2017.
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