D-1278-2020 Class II Ongoing
FDA drug recall D-1278-2020 was initiated by Wuhan Bingbing Pharmaceutical Co., Ltd. on May 19, 2020 and is designated Class II. 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 dat… The recall status is ongoing. Affected quantity: 54,000 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- June 3, 2020
- Initiation Date
- May 19, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54,000 boxes
Product Description
LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1.
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.
Distribution Pattern
Nationwide in the USA
Code Information
Batch #: 170527, Exp 2020.05