Recalls / Class III
Class IIID-1112-2018
Product
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
- Affected lot / code info
- Batch 3096049
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 408 cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2018-08-14
- FDA classified
- 2018-08-22
- Posted by FDA
- 2018-08-29
- Terminated
- 2020-06-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1112-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.