FDA Recall D-0894-2023

Preferred Pharmaceuticals, Inc. · Anaheim, CA

Class II Ongoing 1053 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 Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.

Lot / code: Lot#: a) H1621S, Exp: 12/31/2023; b) H2321C, Exp: 12/31/2023; c) H0421B, Exp: 12/31/2023; d) H1721E, H1921T, H3121M, Exp: 12/31/2023, e) H2021G, Exp: 12/31/2023

Quantity: 541 Bottles

Reason for recall

Failed Stability Specifications

Recall record

Recall number: D-0894-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2023-06-26
Classified by FDA Center: 2023-07-05
FDA published: 2023-07-12
Recalling firm: Preferred Pharmaceuticals, Inc.
Firm location: Anaheim, CA

Drug identification

Brand name(s): TIZANIDINE
Generic name(s): TIZANIDINE
Manufacturer(s): Preferred Pharmaceuticals, Inc.
NDC(s): 68788-7781
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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