Recalls / Class III
Class IIID-0151-2017
Product
Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
- Affected lot / code info
- 0378-5220-01 Lot# 3065133; Exp. 03/17 0378-5220-01 Lot# 3066564; Exp. 05/17 0378-5220-05 Lot# 3066564; Exp. 05/17 0378-5220-01 Lot# 3069645; Exp. 08/17 0378-5220-05 Lot# 3069645; Exp. 08/17
Why it was recalled
Failed Impurities/Degradation Specifications: OOS results for known compound.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 51,983 extended release capsules
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-03
- FDA classified
- 2016-11-23
- Posted by FDA
- 2016-11-30
- Terminated
- 2017-08-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0151-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.