MENTHOL, UNSPECIFIED FORM Recall D-1090-2023
Description: Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004
MENTHOL, UNSPECIFIED FORM Recall D-1090-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1090-2023 |
| Event ID | 92786 |
| Brand | HELIX |
| Generic Name | PAIN RELIEVING CREAM |
| Manufacturer | PAIN RELIEVING CREAM |
| Original Package? | 1 |
| Active Substance | MENTHOL, UNSPECIFIED FORM |
| Drug Route | TOPICAL |
| Distribution | Nationwide within the United States, Singapore, Korea and Hong Kong |
| Quantity | 250 |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20230830 |
| Product NDC | 30775-051 |
| Recall Initiation Date | 20230802 |
| Report Date | 20230830 |
| Classification Date | 20230818 |
| Address | 286 Eldridge Rd Fairfield, NJ 07004-2509 United States |
| Recalling Firm | Parker Laboratories, Inc. |
| Initial Notification | |
| Unique Ingredient Identifier | L7T10EIP3A |
| Drug Application Number | part356 |
| Structured Product Labeling (SPL ID) | ef52d9fa-1436-15d2-e053-2995a90a169c |
| Structured Product Labeling (SPL Set ID) | 73557911-4005-6e66-e053-2a91aa0ac620 |
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