Par Pharmaceutical, Inc. recalls Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by:…
- Recall date
- September 6, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1185-2018
- FDA classification
- Class III
- Brand / firm
- Par Pharmaceutical, Inc.
- Sold / distributed
- United States nationwide
Why it was recalled
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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