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Class III: unlikely to cause harmTerminated

SCA Pharmaceuticals labetalol HCl injection 20 mg/4 mL Recall

labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pha…

SCA Pharmaceuticals, LLC. · Windsor, CT

Risk level
Class III
Reported by FDA
Mar 14, 2018
Recall ID
D-0603-2018
Check your lot numberHow we source this data

Summary

SCA Pharmaceuticals recalled labetalol HCl injection 20 mg/4 mL starting Feb 22, 2018. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0603-2018 on Mar 14, 2018. Reason: Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018. Status: Terminated.

Why it was recalled

Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018

Product description

labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028

Lot numbers, UPCs & expiration codes

lot 1217000213, exp 03/27/2019

Where it was sold

GA, NE & PA

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-0603-2018
Classification
Class III
Status
Terminated
Recall initiated
Feb 22, 2018
FDA report date
Mar 14, 2018
Quantity
480 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
SCA Pharmaceuticals, LLC.

Original FDA data

Every field from FDA enforcement report D-0603-2018, exactly as published.

Show all FDA fields
City
Windsor
State
CT
Status
Terminated
Country
United States
Event ID
79265
Address
755 Rainbow Rd Ste B
Code information
lot 1217000213, exp 03/27/2019
Postal code
06095-1024
Report date
Mar 14, 2018
Product type
Drugs
Recall number
D-0603-2018
Classification
Class III
Recalling firm
SCA Pharmaceuticals, LLC.
Product quantity
480 syringes
Termination date
Feb 26, 2019
Reason for recall
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
Voluntary / mandated
Voluntary: Firm initiated
Product description
labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028
Distribution pattern
GA, NE & PA
Recall initiation date
Feb 22, 2018
Initial firm notification
Letter
Center classification date
Mar 19, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0603-2018, published Mar 14, 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.

How we source and update recall data · Report incorrect information

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