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Class II: temporary or reversible health riskTerminated

RXQ Compounding Procaine Hcl 8% Recall

PROCAINE HCL 8% (PFV) INJECTABLE, 10ML PER VIAL, RXQ Compounding, 340 West State Street…

RXQ Compounding LLC · Athens, OH

Risk level
Class II
Reported by FDA
Aug 14, 2019
Recall ID
D-1698-2019
Check your lot numberHow we source this data

Summary

RXQ Compounding recalled Procaine Hcl 8% starting Jun 19, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1698-2019 on Aug 14, 2019. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

PROCAINE HCL 8% (PFV) INJECTABLE, 10ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0970-10

Lot numbers, UPCs & expiration codes

All lots within expiry

Where it was sold

Nationwide 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-1698-2019
Classification
Class II
Status
Terminated
Recall initiated
Jun 19, 2019
FDA report date
Aug 14, 2019
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
RXQ Compounding LLC

Original FDA data

Every field from FDA enforcement report D-1698-2019, exactly as published.

Show all FDA fields
City
Athens
State
OH
Status
Terminated
Country
United States
Event ID
83074
Address
340 W State St Unit 9
Code information
All lots within expiry
Postal code
45701-1564
Report date
Aug 14, 2019
Product type
Drugs
Recall number
D-1698-2019
Classification
Class II
Recalling firm
RXQ Compounding LLC
Termination date
Sep 16, 2022
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
PROCAINE HCL 8% (PFV) INJECTABLE, 10ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0970-10
Distribution pattern
Nationwide USA
Recall initiation date
Jun 19, 2019
Initial firm notification
Press Release
Center classification date
Aug 8, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1698-2019, published Aug 14, 2019. 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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