Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.
Reported: June 3, 2020 Initiated: May 19, 2020 #D-1279-2020
Product Description
Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.
Reason for Recall
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Details
- Recalling Firm
- Wuhan Bingbing Pharmaceutical Co., Ltd.
- Units Affected
- 1,800 pouches
- Distribution
- Nationwide in the USA
- Location
- Wuhan, N/A
Frequently Asked Questions
What product was recalled? ▼
Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.. Recalled by Wuhan Bingbing Pharmaceutical Co., Ltd.. Units affected: 1,800 pouches.
Why was this product recalled? ▼
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 3, 2020. Severity: Moderate. Recall number: D-1279-2020.
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