Drug product
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
D-1185-2018
Product summary
- Event
- Event 80969
- Status
- Terminated
- Classification
- Class III
- Quantity
- 16,207 (bottles of 30 tablets)
- Official record key
drug-enforcement:D-1185-2018
Official wording
Reason: Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Code information: Lot #: 29906202, Exp 12/18; 29993102, Exp 2/19; 30366102, 30373103, Exp 4/19; 31940601, Exp 3/20.
Distribution pattern: United States nationwide
Derived failure modes
-
Potency or specification failure
Failed impurities/degradation specifications