Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
Reported: February 27, 2019 Initiated: February 13, 2019 #D-0506-2019
Product Description
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 8,159 bottles
- Distribution
- Throughout the United States
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 8,159 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 27, 2019. Severity: Low. Recall number: D-0506-2019.
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