FDA Recall D-0330-2023

Dr. Reddy's Laboratories, Inc. · Princeton, NJ

Class II Ongoing 1191 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot # C2106445; Exp. 03/2024

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 record

Recall number: D-0330-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2023-02-08
Classified by FDA Center: 2023-02-21
FDA published: 2023-03-01
Recalling firm: Dr. Reddy's Laboratories, Inc.
Firm location: Princeton, NJ

Drug identification

Brand name(s): TACROLIMUS
Generic name(s): TACROLIMUS
Manufacturer(s): Dr. Reddy's Laboratories Limited
NDC(s): 55111-525, 55111-526, 55111-527
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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