Par Pharmaceutical Recalls Pramipexole Dihydrochloride Extended Release Tablets
Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because they contain a known impurity above approved specification levels.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a specification failure regarding impurities without reported injuries.
Plain-English summary
Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets, 0.375 mg, Rx Only, 30 count bottles. The recall is due to the presence of a known product impurity above currently approved specification levels.
The affected product is manufactured by Par Pharmaceutical Companies, Inc., located in Chestnut Ridge, NY. The specific NDC number is 10370-251-11. The recall involves 12,535 bottles distributed nationwide and in Puerto Rico.
The affected lots are 27409201, 27409301, and 27409401 with an expiration date of 02/2017, and lot 27662101 with an expiration date of 07/2017. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates.
The recalled product
- Product
- Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11
- Manufacturer
- Par Pharmaceutical
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 12,535
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #s: 27409201
- 27409301
- 27409401
- Exp. 02/2017
- 27662101
- Exp. 07/2017
Distribution
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