Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
Reported: September 3, 2014 Initiated: June 19, 2014 #D-1557-2014
Product Description
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.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 2,658 Bottles
- Distribution
- Nationwide
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 2,658 Bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 3, 2014. Severity: Low. Recall number: D-1557-2014.
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