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Class II: temporary or reversible health riskTerminated

SCA Pharmaceuticals Lidocaine HCl 2% 5 mL Recall

Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor,…

SCA Pharmaceuticals, LLC · Windsor, CT

Risk level
Class II
Reported by FDA
Dec 18, 2019
Recall ID
D-0620-2020
Check your lot numberHow we source this data

Summary

SCA Pharmaceuticals recalled Lidocaine HCl 2% 5 mL starting Nov 26, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0620-2020 on Dec 18, 2019. Reason: Presence of Foreign Substance: Foreign material found inside the vial (manufacturer). Status: Terminated.

Why it was recalled

Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).

Product description

Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09

Lot numbers, UPCs & expiration codes

1219012595 29-Dec-19 1219012647 01-Jan-20

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-0620-2020
Classification
Class II
Status
Terminated
Recall initiated
Nov 26, 2019
FDA report date
Dec 18, 2019
Quantity
1363 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
SCA Pharmaceuticals, LLC

Original FDA data

Every field from FDA enforcement report D-0620-2020, exactly as published.

Show all FDA fields
City
Windsor
State
CT
Status
Terminated
Country
United States
Event ID
84326
Address
755 Rainbow Rd Ste B
Code information
1219012595 29-Dec-19 1219012647 01-Jan-20
Postal code
06095-1024
Report date
Dec 18, 2019
Product type
Drugs
Recall number
D-0620-2020
Classification
Class II
Recalling firm
SCA Pharmaceuticals, LLC
Product quantity
1363 syringes
Termination date
Feb 7, 2020
Reason for recall
Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
Distribution pattern
nationwide
Recall initiation date
Nov 26, 2019
Initial firm notification
Letter
Center classification date
Dec 10, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0620-2020, published Dec 18, 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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