Recalls / Class III
Class IIID-0180-2021
Product
NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816
- Brand name
- Tacrolimus
- Generic name
- Tacrolimus
- Active ingredient
- Tacrolimus
- Route
- Oral
- NDCs
- 64380-720, 64380-721, 64380-722
- FDA application
- ANDA090687
- Affected lot / code info
- Lot 7242728A; June 2023
Why it was recalled
Failed Moisture Limits
Recalling firm
- Firm
- Strides Pharma Inc.
- Manufacturer
- Strides Pharma Science Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1102, N/A, East Brunswick, New Jersey 08816-1100
Distribution
- Quantity
- 960 bottles
- Distribution pattern
- PA
Timeline
- Recall initiated
- 2020-12-22
- FDA classified
- 2020-12-30
- Posted by FDA
- 2021-01-06
- Terminated
- 2022-01-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0180-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.