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.
Reported: February 17, 2016 Initiated: December 24, 2015 #D-0653-2016
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.
Reason for Recall
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Details
- Recalling Firm
- Macleods Pharma Usa Inc
- Units Affected
- N/A
- Distribution
- US Nationwide.
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Macleods Pharma Usa Inc. Units affected: N/A.
Why was this product recalled? ▼
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 17, 2016. Severity: Moderate. Recall number: D-0653-2016.
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