Par Pharmaceutical Recalls Pramipexole Dihydrochloride Extended Release Tablets
Par Pharmaceutical is recalling Pramipexole dihydrochloride extended release tablets because they contain a known impurity at levels exceeding specifications.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition indicates a low risk of adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Par Pharmaceutical, Inc. is recalling Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles. The recall involves 16,207 bottles distributed nationwide in the United States. The affected lots are 29906202 (Exp 12/18), 29993102 (Exp 2/19), 30366102 and 30373103 (Exp 4/19), and 31940601 (Exp 3/20).
The recall was initiated because the finished product contains a known product impurity at levels that exceed current specifications. This is a Class III recall, which the FDA defines as a situation in which there is little or no reasonable chance that the use of the product will cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider regarding alternative treatment options if necessary.
The recalled product
- Product
- 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
- Manufacturer
- Par Pharmaceutical, Inc.
- Category
- Drug — Prescription Medication
- Hazard
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 (9)
- Lot #: 29906202
- Exp 12/18
- 29993102
- Exp 2/19
- 30366102
- 30373103
- Exp 4/19
- 31940601
- Exp 3/20.
Distribution
Distributed nationwide across the United States.
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