Recalls / Class III
Class IIID-0556-2023
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
- Brand name
- Lidocaine
- Generic name
- Lidocaine
- Active ingredient
- Lidocaine
- Route
- Topical
- NDC
- 63629-8755
- FDA application
- ANDA200675
- Affected lot / code info
- 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.
Why it was recalled
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.
Recalling firm
- Firm
- Bryant Ranch Prepack, Inc.
- Manufacturer
- Bryant Ranch Prepack
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1919 N Victory Pl, Burbank, California 91504-3425
Distribution
- Quantity
- 403 boxes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-04-20
- FDA classified
- 2023-04-28
- Posted by FDA
- 2023-05-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0556-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.