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Class I: serious health riskTerminated

SCA Pharmaceuticals Vancomycin HCl 750 mg added to 5% Dextrose Recall

Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmac…

SCA Pharmaceuticals · Little Rock, AR

Risk level
Class I
Reported by FDA
Apr 12, 2017
Recall ID
D-0645-2017
Check your lot numberHow we source this data

Summary

SCA Pharmaceuticals recalled Vancomycin HCl 750 mg added to 5% Dextrose starting Feb 3, 2017. The FDA classified it as Class I (serious health risk) and published enforcement report D-0645-2017 on Apr 12, 2017. Reason: Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. Status: Terminated.

Why it was recalled

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

Product description

Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40

Lot numbers, UPCs & expiration codes

Lot: 20161219@3, Exp 2/2/2017

Where it was sold

U.S. 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-0645-2017
Classification
Class I
Status
Terminated
Recall initiated
Feb 3, 2017
FDA report date
Apr 12, 2017
Quantity
62 bags
Recall type
Voluntary: Firm initiated
Recalling firm
SCA Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-0645-2017, exactly as published.

Show all FDA fields
City
Little Rock
State
AR
Status
Terminated
Country
United States
Event ID
76395
Address
8821 Knoedl Ct
Code information
Lot: 20161219@3, Exp 2/2/2017
Postal code
72205-4600
Report date
Apr 12, 2017
Product type
Drugs
Recall number
D-0645-2017
Classification
Class I
Recalling firm
SCA Pharmaceuticals
Product quantity
62 bags
Termination date
Oct 19, 2017
Reason for recall
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40
Distribution pattern
U.S. Nationwide
Recall initiation date
Feb 3, 2017
Initial firm notification
Letter
Center classification date
Apr 5, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0645-2017, published Apr 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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