Class III
Terminated
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
- Company
- Par Pharmaceutical, Inc.
- Recall Initiated
- September 6, 2018
- Posted
- September 19, 2018
- Recall Number
- D-1185-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,207 (bottles of 30 tablets)
- Firm Location
- Chestnut Ridge, NY, United States
Reason for Recall
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Distribution
United States nationwide
Lot / Code Info
Lot #: 29906202, Exp 12/18; 29993102, Exp 2/19; 30366102, 30373103, Exp 4/19; 31940601, Exp 3/20.
More recalls by Par Pharmaceutical, Inc.
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Sep 2, 2020 · Class II
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Apr 8, 2020 · Class II
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnu...
Mar 25, 2020 · Class III
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