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
Reported: September 19, 2018 Initiated: September 6, 2018 #D-1185-2018
Product Description
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
Reason for Recall
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Details
- Recalling Firm
- Par Pharmaceutical, Inc.
- Units Affected
- 16,207 (bottles of 30 tablets)
- Distribution
- United States nationwide
- Location
- Chestnut Ridge, NY
Frequently Asked Questions
What product 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. Recalled by Par Pharmaceutical, Inc.. Units affected: 16,207 (bottles of 30 tablets).
Why was this product recalled? ▼
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 19, 2018. Severity: Low. Recall number: D-1185-2018.
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