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Class II: temporary or reversible health riskTerminated

Shadow Holdings DBA Bocchi Labs X-Jow Recall

X-Jow (menthol USP) Pain Gel, 1

Shadow Holdings DBA Bocchi Labs · Santa Clarita, CA

Risk level
Class II
Reported by FDA
Jun 20, 2018
Recall ID
D-0858-2018
Check your lot numberHow we source this data

Summary

Shadow Holdings DBA Bocchi Labs recalled X-Jow starting May 25, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0858-2018 on Jun 20, 2018. Reason: CGMP Deviations: products may be contaminated with bacteria. Status: Terminated.

Why it was recalled

CGMP Deviations: products may be contaminated with bacteria.

Product description

X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.

Lot numbers, UPCs & expiration codes

All lots

Where it was sold

Nationwide in the USA

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-0858-2018
Classification
Class II
Status
Terminated
Recall initiated
May 25, 2018
FDA report date
Jun 20, 2018
Quantity
12,252 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Shadow Holdings DBA Bocchi Labs

Original FDA data

Every field from FDA enforcement report D-0858-2018, exactly as published.

Show all FDA fields
City
Santa Clarita
State
CA
Status
Terminated
Country
United States
Event ID
80184
Address
26421 Ruether Ave
Code information
All lots
Postal code
91350-2621
Report date
Jun 20, 2018
Product type
Drugs
Recall number
D-0858-2018
Classification
Class II
Recalling firm
Shadow Holdings DBA Bocchi Labs
Product quantity
12,252 bottles
Termination date
Aug 13, 2019
Reason for recall
CGMP Deviations: products may be contaminated with bacteria.
Voluntary / mandated
Voluntary: Firm initiated
Product description
X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.
Distribution pattern
Nationwide in the USA
Recall initiation date
May 25, 2018
Initial firm notification
Press Release
Center classification date
Jun 12, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0858-2018, published Jun 20, 2018. 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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