Drug product
Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.
D-1111-2015
Product summary
- Firm
- Mylan Lab Inc
- Event
- Event 71218
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,722 bottles
- Official record key
drug-enforcement:D-1111-2015
Official wording
Reason: Failed Dissolution Specifications: Low out of specification dissolution results.
Code information: Lot #: 3059043, Exp 08/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification