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Class II: temporary or reversible health riskTerminated

SCA Pharmaceuticals morphine sulfate 150 mg/30 mL in 0 Recall

morphine sulfate 150 mg/30 mL in 0

SCA Pharmaceuticals · Windsor, CT

Risk level
Class II
Reported by FDA
Jan 13, 2021
Recall ID
D-0202-2021
Check your lot numberHow we source this data

Summary

SCA Pharmaceuticals recalled morphine sulfate 150 mg/30 mL in 0 starting Dec 17, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0202-2021 on Jan 13, 2021. Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

Product description

morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316

Lot numbers, UPCs & expiration codes

Lot # 1220023221, BUD 1/31/2021 & 1220023584, BUD 2/9/2021.

Where it was sold

Product was distributed to hospitals 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-0202-2021
Classification
Class II
Status
Terminated
Recall initiated
Dec 17, 2020
FDA report date
Jan 13, 2021
Quantity
50 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
SCA Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-0202-2021, exactly as published.

Show all FDA fields
City
Windsor
State
CT
Status
Terminated
Country
United States
Event ID
86990
Address
755 Rainbow Rd Ste B
Code information
Lot # 1220023221, BUD 1/31/2021 & 1220023584, BUD 2/9/2021.
Postal code
06095-1024
Report date
Jan 13, 2021
Product type
Drugs
Recall number
D-0202-2021
Classification
Class II
Recalling firm
SCA Pharmaceuticals
Product quantity
50 syringes
Termination date
Nov 2, 2021
Reason for recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Voluntary / mandated
Voluntary: Firm initiated
Product description
morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316
Distribution pattern
Product was distributed to hospitals nationwide.
Recall initiation date
Dec 17, 2020
Initial firm notification
Letter
Center classification date
Jan 7, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0202-2021, published Jan 13, 2021. 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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