Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10
Reported: September 18, 2019 Initiated: August 21, 2019 #D-1851-2019
Product Description
Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10
Reason for Recall
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Details
- Recalling Firm
- Macleods Pharma Usa Inc
- Units Affected
- 1837 90-count bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10. Recalled by Macleods Pharma Usa Inc. Units affected: 1837 90-count bottles.
Why was this product recalled? ▼
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 18, 2019. Severity: Low. Recall number: D-1851-2019.
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