D-0068-2019 Class II Terminated
FDA drug recall D-0068-2019 was initiated by Product Quest Manufacturing LLC on Aug 3, 2018 and is designated Class II. Reason for recall: Superpotent Drug: high out of specification assay results for the menthol ingredient. The recall status is terminated (terminated Mar 30, 2021). Affected quantity: 4,692 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 24, 2018
- Initiation Date
- Aug 3, 2018
- Termination Date
- Mar 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,692 tubes
Product Description
Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd., Suite 101, Boca Raton, FL, 33431, UPC 8 40986 01341
Reason for Recall
Superpotent Drug: high out of specification assay results for the menthol ingredient.
Distribution Pattern
Nationwide in the USA
Code Information
Lot. 172598G, Exp. 7/4/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0068-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026