Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
Reported: July 23, 2014 Initiated: July 3, 2014 #D-1435-2014
Product Description
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
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 Institutional, Inc. (d.b.a. UDL Laboratories)
- Units Affected
- 1,184 cartons
- Distribution
- Nationwide, Puerto Rico, and Guam.
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: 1,184 cartons.
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 July 23, 2014. Severity: Low. Recall number: D-1435-2014.
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