Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09
Reported: February 12, 2020 Initiated: January 24, 2020 #D-0838-2020
Product Description
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09
Reason for Recall
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Details
- Recalling Firm
- Macleods Pharma Usa Inc
- Units Affected
- 4694 30x60-count bottles
- Distribution
- Nationwide
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09. Recalled by Macleods Pharma Usa Inc. Units affected: 4694 30x60-count bottles.
Why was this product recalled? ▼
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 12, 2020. Severity: Low. Recall number: D-0838-2020.
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