Class II · Moderate risk
Lidocaine Ointment USP
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Lidocaine Patch 5%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30
Affected NDC
0591-3525-30
Compare with the code on your package — it is the most precise check available.
Drug: Lidocaine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Lidocaine NDC 00591-3525 |
50 mg/g | Patch Topical |
Actavis Pharma, Inc. | Rx |
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0591-3525-30
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1492-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Lidocaine recalls
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Class II · Moderate risk
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Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
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Class III · Low risk
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Class II · Moderate risk
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