Recalls / Class II
Class IID-0819-2018
Product
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
- Affected lot / code info
- Lot Numbers# 3083005, 3083006, 3086121, and 3086122, exp Jan 2019
Why it was recalled
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 25,488 bottles
- Distribution pattern
- Product was distributed throughout United States
Timeline
- Recall initiated
- 2018-04-24
- FDA classified
- 2018-05-17
- Posted by FDA
- 2018-05-23
- Terminated
- 2019-06-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0819-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.