Recalls / Class III
Class IIID-1185-2018
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
- Affected lot / code info
- Lot #: 29906202, Exp 12/18; 29993102, Exp 2/19; 30366102, 30373103, Exp 4/19; 31940601, Exp 3/20.
Why it was recalled
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Recalling firm
- Firm
- Par Pharmaceutical, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Ram Ridge Rd, N/A, Chestnut Ridge, New York 10977-6714
Distribution
- Quantity
- 16,207 (bottles of 30 tablets)
- Distribution pattern
- United States nationwide
Timeline
- Recall initiated
- 2018-09-06
- FDA classified
- 2018-09-10
- Posted by FDA
- 2018-09-19
- Terminated
- 2019-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1185-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.