FDA Recall D-0556-2023

Bryant Ranch Prepack, Inc. · Burbank, CA

Class III Ongoing 1120 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA

Lot / code: Lot: 204603, Exp: 09/30/2024; Lots:208608, 208749, 208445, 209101, 208609, 208295, 209106, 209102, 209212, 208975, 209211, 209706, 209779, 209624, 209839, 209548, Exp: 12/31/2024; Lots: 204604, 204601, 204550, 204599, 204871, 204555, 205616, Exp: 11/30/2024; Lots: 205612, 204832, 205127, 204996, 205615, 205324, 205494, 205611, 206232, Exp: 10/31/2024.

Quantity: 403 boxes

Reason for recall

Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.

Recall record

Recall number: D-0556-2023
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2023-04-20
Classified by FDA Center: 2023-04-28
FDA published: 2023-05-10
Recalling firm: Bryant Ranch Prepack, Inc.
Firm location: Burbank, CA

Drug identification

Brand name(s): LIDOCAINE
Generic name(s): LIDOCAINE
Manufacturer(s): Bryant Ranch Prepack
NDC(s): 63629-8755
Route(s): TOPICAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

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

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