D-0857-2018 Class III Terminated
FDA drug recall D-0857-2018 was initiated by Teva Pharmaceuticals USA on Apr 30, 2018 and is designated Class III. Reason for recall: Failed Stability Specifications The recall status is terminated (terminated Jan 14, 2019). Affected quantity: 30,382 patches.
Recall Details
- Product Type
- Drugs
- Report Date
- May 30, 2018
- Initiation Date
- Apr 30, 2018
- Termination Date
- Jan 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,382 patches
Product Description
Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)
Reason for Recall
Failed Stability Specifications
Distribution Pattern
United States
Code Information
Carton Lot Number:1147020B Patch (Envelope) Lot Number: 1147020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0857-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026