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Class II: temporary or reversible health riskTerminated

Parker Laboratories Helix CBD Therapy Cream Recall

Helix CBD Therapy Cream (Menthol 7

Parker Laboratories, Inc. · Fairfield, NJ

Risk level
Class II
Reported by FDA
Aug 30, 2023
Recall ID
D-1092-2023
Check your lot numberHow we source this data

Summary

Parker Laboratories recalled Helix CBD Therapy Cream starting Aug 2, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1092-2023 on Aug 30, 2023. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004

Lot numbers, UPCs & expiration codes

Lot #: a) J1121010, Exp. Date 12/16/2023, b) A0921006, Exp. Date 8/16/2023, c) A0921007, Exp. Date 8/16/2023

Where it was sold

Nationwide within the United States, Singapore, Korea and Hong Kong

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1092-2023
Classification
Class II
Status
Terminated
Recall initiated
Aug 2, 2023
FDA report date
Aug 30, 2023
Quantity
40
Recall type
Voluntary: Firm initiated
Recalling firm
Parker Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-1092-2023, exactly as published.

Show all FDA fields
City
Fairfield
State
NJ
Status
Terminated
Country
United States
Event ID
92786
Address
286 Eldridge Rd
Code information
Lot #: a) J1121010, Exp. Date 12/16/2023, b) A0921006, Exp. Date 8/16/2023, c) A0921007, Exp. Date 8/16/2023
Postal code
07004-2509
Report date
Aug 30, 2023
Product type
Drugs
Recall number
D-1092-2023
Classification
Class II
Recalling firm
Parker Laboratories, Inc.
Product quantity
40
Termination date
Jun 3, 2024
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004
Distribution pattern
Nationwide within the United States, Singapore, Korea and Hong Kong
Recall initiation date
Aug 2, 2023
Initial firm notification
E-Mail
Center classification date
Aug 18, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1092-2023, published Aug 30, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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