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Class II: temporary or reversible health riskTerminated

Advanced Pharma 2% Lidocaine HCl Injectable Solution Recall

2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use…

Advanced Pharma Inc. · Houston, TX

Risk level
Class II
Reported by FDA
Mar 27, 2019
Recall ID
D-1026-2019
Check your lot numberHow we source this data

Summary

Advanced Pharma recalled 2% Lidocaine HCl Injectable Solution starting Mar 13, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1026-2019 on Mar 27, 2019. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

Lot numbers, UPCs & expiration codes

Lot: 10/18/18 2217 01122S Exp. 3/17/2019

Where it was sold

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-1026-2019
Classification
Class II
Status
Terminated
Recall initiated
Mar 13, 2019
FDA report date
Mar 27, 2019
Quantity
1540 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Advanced Pharma Inc.

Original FDA data

Every field from FDA enforcement report D-1026-2019, exactly as published.

Show all FDA fields
City
Houston
State
TX
Status
Terminated
Country
United States
Event ID
82398
Address
9265 Kirby Dr
Code information
Lot: 10/18/18 2217 01122S Exp. 3/17/2019
Postal code
77054-2520
Report date
Mar 27, 2019
Product type
Drugs
Recall number
D-1026-2019
Classification
Class II
Recalling firm
Advanced Pharma Inc.
Product quantity
1540 syringes
Termination date
Jan 14, 2020
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Distribution pattern
Nationwide
Recall initiation date
Mar 13, 2019
Initial firm notification
Letter
Center classification date
Mar 21, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1026-2019, published Mar 27, 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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