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Class II: temporary or reversible health riskTerminated

SCA Pharmaceuticals SUCcinylcholine 20 mg per mL Recall

SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholi…

SCA Pharmaceuticals, LLC · Little Rock, AR

Risk level
Class II
Reported by FDA
Nov 8, 2017
Recall ID
D-0059-2018
Check your lot numberHow we source this data

Summary

SCA Pharmaceuticals recalled SUCcinylcholine 20 mg per mL starting Oct 19, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0059-2018 on Nov 8, 2017. Reason: Lack Of Assurance Of Sterility. Status: Terminated.

Why it was recalled

Lack Of Assurance Of Sterility.

Product description

SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29

Lot numbers, UPCs & expiration codes

Lot: 20170726@35 BUD: 10/24/2017

Where it was sold

Nationwide in the United States

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-0059-2018
Classification
Class II
Status
Terminated
Recall initiated
Oct 19, 2017
FDA report date
Nov 8, 2017
Quantity
1248 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
SCA Pharmaceuticals, LLC

Original FDA data

Every field from FDA enforcement report D-0059-2018, exactly as published.

Show all FDA fields
City
Little Rock
State
AR
Status
Terminated
Country
United States
Event ID
78320
Address
8821 Knoedl Ct
Code information
Lot: 20170726@35 BUD: 10/24/2017
Postal code
72205-4600
Report date
Nov 8, 2017
Product type
Drugs
Recall number
D-0059-2018
Classification
Class II
Recalling firm
SCA Pharmaceuticals, LLC
Product quantity
1248 syringes
Termination date
May 1, 2019
Reason for recall
Lack Of Assurance Of Sterility.
Voluntary / mandated
Voluntary: Firm initiated
Product description
SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29
Distribution pattern
Nationwide in the United States
Recall initiation date
Oct 19, 2017
Initial firm notification
Letter
Center classification date
Nov 2, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0059-2018, published Nov 8, 2017. 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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