Drug recall: Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each…
Class III FDA enforcement event 92161. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Bryant Ranch Prepack, Inc. started this drug recall on 20 Apr 2023. The firm address in the FDA record is in Burbank, CA. FDA put the recall in Class III. FDA event 92161 has 1 product record. The first FDA enforcement report date is 10 May 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide in the USA
Recalling firm
Bryant Ranch Prepack, Inc., Burbank, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0556-2023 | 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 | 403 boxes | Class III | Ongoing | 10 May 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Drug events that started in 2023
- 281
- Share of these events in Class III
- 26%
- Product records in this event
- 1Median of the firm: 2
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 May 2024 | Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burba | Drug | Class III | 5 |
| 17 Jun 2022 | Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc | Drug | Class I | 2 |
| 27 Jul 2018 | Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629- | Drug | Class II | 3 |
| 25 Mar 2016 | Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle ( | Drug | Class III | 1 |
Official channels
- FDA enforcement report D-0556-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 92161. https://recallregister.com/fda/iii/92161/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide in the USA
- What quantity of product is in FDA event 92161?
- The FDA record gives this quantity:
403 boxes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2023 have the same class?
- 26% of the 281 drug events that started in 2023 are in Class III.