Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
Reported: August 29, 2018 Initiated: August 14, 2018 #D-1112-2018
Product Description
Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
Reason for Recall
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Details
- Recalling Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Units Affected
- 408 cartons
- Distribution
- Nationwide USA
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: 408 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 29, 2018. Severity: Low. Recall number: D-1112-2018.
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