Status
Terminated
Drug Enforcement D-1090-2023
CGMP Deviations
Classification
Class II
Report Date
August 30, 2023
Termination Date
June 3, 2024
Product Information
- Product 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
- Product quantity
- 250
- Reason for recall
- CGMP Deviations
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide within the United States, Singapore, Korea and Hong Kong
Location & Firm
- Recalling firm
- Parker Laboratories, Inc.
- Address
-
286 Eldridge Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1090-2023
- Event ID
- 92786
- Recall initiation date
- August 2, 2023
- Center classification date
- August 18, 2023
- Code info
- a) J0721010, Exp. Date 6/30/2024; J1022017, Exp. Date 10/27/2025; b) A0521002, Exp. Date 4/29/2024; c) A0322006, Exp. Date 3/2/2025, A0323004, Exp. Date 2/24/2026, A0422005, Exp. Date 3/14/2025, A0521001, Exp. Date 4/29/2024, A0822004, Exp. Date 7/27/2025, d) C0222001, Exp. Date 6/30/2023, C0521003, Exp. Date 4/29/2023, C0822005, Exp. Date 7/27/2024, e)C0721019, Exp. Date 6/30/2024, f) C0521001, Exp. Date 4/29/2024, C0721022, Exp. Date 6/30/2024, C0822006, Exp. Date 7/27/2025, g) C0323006, C0821022, C0922006, Exp. Date 4/29/2024, C1221003, Exp. Date 4/09/2024
- More code info
- —