D-0330-2023 Class II Ongoing
FDA drug recall D-0330-2023 was initiated by Dr. Reddy's Laboratories, Inc. on February 8, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 4,320 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 1, 2023
- Initiation Date
- February 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,320 bottles
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.
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # C2106445; Exp. 03/2024