Recalls / Class II
Class IID-0330-2023
Product
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.
- Brand name
- Tacrolimus
- Generic name
- Tacrolimus
- Active ingredient
- Tacrolimus
- Route
- Oral
- NDCs
- 55111-525, 55111-526, 55111-527
- FDA application
- ANDA090509
- Affected lot / code info
- Lot # C2106445; Exp. 03/2024
Why it was recalled
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 4,320 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-02-08
- FDA classified
- 2023-02-21
- Posted by FDA
- 2023-03-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0330-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.