Why it was recalled
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Product description
Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.
Lot numbers, UPCs & expiration codes
Lot #: BPA512A; Expiry: 06/2017.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0653-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 24, 2015
- FDA report date
- Feb 17, 2016
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-0653-2016, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 73017
- Address
- 666 Plainsboro Rd
- Address (line 2)
- Bldg 200 Ste 230
- Code information
- Lot #: BPA512A; Expiry: 06/2017.
- Postal code
- 08536-3030
- Report date
- Feb 17, 2016
- Product type
- Drugs
- Recall number
- D-0653-2016
- Classification
- Class II
- Recalling firm
- Macleods Pharma Usa Inc
- Termination date
- Aug 31, 2020
- Reason for recall
- Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Dec 24, 2015
- Initial firm notification
- Letter
- Center classification date
- Feb 5, 2016