Status
Ongoing
Drug Enforcement D-0330-2023
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.
Classification
Class II
Report Date
March 1, 2023
Termination Date
—
Product Information
- 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.
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Address
-
107 College Rd E, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0330-2023
- Event ID
- 91661
- Recall initiation date
- February 8, 2023
- Center classification date
- February 21, 2023
- Code info
- Lot # C2106445; Exp. 03/2024
- More code info
- —