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Class II: temporary or reversible health riskTerminated

Fagron Compounding Services LLC dba Fagron Sterile Services Succinylcholine Chloride Recall

Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe

Fagron Compounding Services LLC dba Fagron Sterile Services · Wichita, KS

Risk level
Class II
Reported by FDA
Jul 12, 2017
Recall ID
D-0946-2017
Check your lot numberHow we source this data

Summary

Fagron Compounding Services LLC dba Fagron Sterile Services recalled Succinylcholine Chloride starting Jun 19, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0946-2017 on Jul 12, 2017. Reason: Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier. Status: Terminated.

Why it was recalled

Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier

Product description

Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405

Lot numbers, UPCs & expiration codes

Lot #: C274-000000331, BUD 08/30/2017; C274-000001274, BUD 09/07/2017; C274-000001326, BUD 09/14/2017

Where it was sold

Nationwide in the USA

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-0946-2017
Classification
Class II
Status
Terminated
Recall initiated
Jun 19, 2017
FDA report date
Jul 12, 2017
Quantity
1,056 5mL syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Fagron Compounding Services LLC dba Fagron Sterile Services

Original FDA data

Every field from FDA enforcement report D-0946-2017, exactly as published.

Show all FDA fields
City
Wichita
State
KS
Status
Terminated
Country
United States
Event ID
77584
Address
8710 E 34th St N
Code information
Lot #: C274-000000331, BUD 08/30/2017; C274-000001274, BUD 09/07/2017; C274-000001326, BUD 09/14/2017
Postal code
67226-2636
Report date
Jul 12, 2017
Product type
Drugs
Recall number
D-0946-2017
Classification
Class II
Recalling firm
Fagron Compounding Services LLC dba Fagron Sterile Services
Product quantity
1,056 5mL syringes
Termination date
Jun 12, 2018
Reason for recall
Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier
Voluntary / mandated
Voluntary: Firm initiated
Product description
Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405
Distribution pattern
Nationwide in the USA
Recall initiation date
Jun 19, 2017
Initial firm notification
Letter
Center classification date
Jul 6, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0946-2017, published Jul 12, 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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