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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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