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Class II: temporary or reversible health riskTerminated

SCA Pharmaceuticals Droperidol injection Recall

Droperidol injection, 2

SCA Pharmaceuticals · Little Rock, AR

Risk level
Class II
Reported by FDA
Apr 29, 2015
Recall ID
D-0965-2015
Check your lot numberHow we source this data

Summary

SCA Pharmaceuticals recalled Droperidol injection starting Feb 24, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0965-2015 on Apr 29, 2015. Reason: Presence of particulate. Status: Terminated.

Why it was recalled

Presence of particulate.

Product description

Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag, RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-7720-16

Lot numbers, UPCs & expiration codes

Lot: 20141223@20

Where it was sold

IN, AR, MO, MN

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-0965-2015
Classification
Class II
Status
Terminated
Recall initiated
Feb 24, 2015
FDA report date
Apr 29, 2015
Quantity
421 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
SCA Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-0965-2015, exactly as published.

Show all FDA fields
City
Little Rock
State
AR
Status
Terminated
Country
United States
Event ID
70583
Address
8821 Knoedl Ct
Code information
Lot: 20141223@20
Postal code
72205-4600
Report date
Apr 29, 2015
Product type
Drugs
Recall number
D-0965-2015
Classification
Class II
Recalling firm
SCA Pharmaceuticals
Product quantity
421 syringes
Termination date
Dec 9, 2016
Reason for recall
Presence of particulate.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag, RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-7720-16
Distribution pattern
IN, AR, MO, MN
Recall initiation date
Feb 24, 2015
Initial firm notification
Letter
Center classification date
Apr 22, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0965-2015, published Apr 29, 2015. 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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