Recalls / Class II
Class IID-0140-2020
Product
Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India NDC 33342-054-07
- Brand name
- Pioglitazone
- Generic name
- Pioglitazone
- Active ingredient
- Pioglitazone Hydrochloride
- Route
- Oral
- NDCs
- 33342-054, 33342-055, 33342-056
- FDA application
- ANDA202467
- Affected lot / code info
- Lot # BPF901A, exp. date 12/2021
Why it was recalled
Superpotent
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- 31,968 bottles
- Distribution pattern
- Product was shipped to 8 distributors who may have further distributed the product.
Timeline
- Recall initiated
- 2019-09-23
- FDA classified
- 2019-10-11
- Posted by FDA
- 2019-10-23
- Terminated
- 2021-02-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0140-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.