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Class II: temporary or reversible health riskTerminated

RXQ Compounding Lidocaine 1% + Epinephrine 1:100 Recall

Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340…

RXQ Compounding LLC · Athens, OH

Risk level
Class II
Reported by FDA
Oct 31, 2018
Recall ID
D-0130-2019
Check your lot numberHow we source this data

Summary

RXQ Compounding recalled Lidocaine 1% + Epinephrine 1:100 starting Sep 25, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0130-2019 on Oct 31, 2018. Reason: Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent. Status: Terminated.

Why it was recalled

Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.

Product description

Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450

Lot numbers, UPCs & expiration codes

Lot# 04042018:58, Exp 10/17/18

Where it was sold

U.S.A. nationwide

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-0130-2019
Classification
Class II
Status
Terminated
Recall initiated
Sep 25, 2018
FDA report date
Oct 31, 2018
Quantity
395 vials
Recall type
Voluntary: Firm initiated
Recalling firm
RXQ Compounding LLC

Original FDA data

Every field from FDA enforcement report D-0130-2019, exactly as published.

Show all FDA fields
City
Athens
State
OH
Status
Terminated
Country
United States
Event ID
81316
Address
340 W State St Unit 9
Code information
Lot# 04042018:58, Exp 10/17/18
Postal code
45701-1564
Report date
Oct 31, 2018
Product type
Drugs
Recall number
D-0130-2019
Classification
Class II
Recalling firm
RXQ Compounding LLC
Product quantity
395 vials
Termination date
Oct 18, 2022
Reason for recall
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450
Distribution pattern
U.S.A. nationwide
Recall initiation date
Sep 25, 2018
Initial firm notification
Letter
Center classification date
Nov 1, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0130-2019, published Oct 31, 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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