FDA Recall D-0923-2023

Dr Reddy's Laboratories Limited · Ranasthalam Mandal, Srikakulam, N/A

Class II Ongoing 1058 days on record

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

Product

Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10

Lot / code: Lot: T2100585, T2100586, T2100587, Exp 12/2023

Quantity: 17,548 1000-countbottles

Reason for recall

Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

Recall record

Recall number: D-0923-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: N/A
Firm notification: N/A
Distribution: Nationwide in the USA
Recall initiated: 2023-06-21
Classified by FDA Center: 2023-07-17
FDA published: 2023-07-26
Recalling firm: Dr Reddy's Laboratories Limited
Firm location: Ranasthalam Mandal, Srikakulam, N/A, India

Drug identification

Brand name(s): TIZANIDINE
Generic name(s): TIZANIDINE
Manufacturer(s): Dr. Reddy's Laboratories Limited
NDC(s): 55111-179, 55111-180
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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