Macleods Pramipexole Dihydrochloride Tablets Recalled for Foreign Tablet Presence
Macleods Pharma USA is recalling Pramipexole Dihydrochloride tablets due to the presence of a foreign Carbimazole 5 mg tablet.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of a foreign medication (Carbimazole) in a prescription drug poses a risk of harm, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Macleods Pharma USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. The recall is being conducted because of the presence of a comingled Carbimazole 5 mg tablet in the product.
The affected product is identified by Lot # BPA512A with an expiry date of 06/2017. The product was distributed nationwide in the United States. It was manufactured for Macleods Pharma USA, Inc. in Plainsboro, NJ, and manufactured by Macleods Pharmaceuticals Ltd. in Baddi, Himachal Pradesh, India.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
- Brand
- PRAMIPEXOLE DIHYDROCHLORIDE
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Drug
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 (2)
- Lot #: BPA512A
- Expiry: 06/2017.
UPCs (5)
- 0333342031105
- 0333342035103
- 0333342034106
- 0333342033109
- 0333342032102
Distribution
Distributed nationwide across the United States.
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