Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
Reported: September 19, 2018 Initiated: August 7, 2018 #D-1186-2018
Product Description
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 11,799 bottles of 100
- Distribution
- Distributed Nationwide in the US
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 11,799 bottles of 100.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 19, 2018. Severity: Low. Recall number: D-1186-2018.
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