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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # C2106445; Exp. 03/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0330-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 8, 2023
- FDA report date
- Mar 1, 2023
- Quantity
- 4,320 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0330-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 91661
- Address
- 107 College Rd E
- Code information
- Lot # C2106445; Exp. 03/2024
- Postal code
- 08540-6623
- Report date
- Mar 1, 2023
- Product type
- Drugs
- Recall number
- D-0330-2023
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 4,320 bottles
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 8, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 21, 2023