Recalls / Class III
Class IIID-0857-2018
Product
Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)
- Brand name
- Lidocaine
- Generic name
- Lidocaine
- Active ingredient
- Lidocaine
- Route
- Topical
- NDC
- 0591-3525
- FDA application
- ANDA200675
- Affected lot / code info
- Carton Lot Number:1147020B Patch (Envelope) Lot Number: 1147020
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 30,382 patches
- Distribution pattern
- United States
Timeline
- Recall initiated
- 2018-04-30
- FDA classified
- 2018-06-11
- Posted by FDA
- 2018-05-30
- Terminated
- 2019-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0857-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.