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Class II: temporary or reversible health riskTerminated

Apollo Care Vancomycin 1g added to 250mL of 0 Recall

Vancomycin 1g added to 250mL of 0

Apollo Care · Columbia, MO

Risk level
Class II
Reported by FDA
Apr 4, 2018
Recall ID
D-0614-2018
Check your lot numberHow we source this data

Summary

Apollo Care recalled Vancomycin 1g added to 250mL of 0 starting Mar 7, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0614-2018 on Apr 4, 2018. Reason: Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. Status: Terminated.

Why it was recalled

Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.

Product description

Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.

Lot numbers, UPCs & expiration codes

Lot#: AC-015565, Exp. 03/26/2018

Where it was sold

Medical Facility in MO

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-0614-2018
Classification
Class II
Status
Terminated
Recall initiated
Mar 7, 2018
FDA report date
Apr 4, 2018
Quantity
144 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Apollo Care

Original FDA data

Every field from FDA enforcement report D-0614-2018, exactly as published.

Show all FDA fields
City
Columbia
State
MO
Status
Terminated
Country
United States
Event ID
79517
Address
3801 Mojave Ct Ste 101
Code information
Lot#: AC-015565, Exp. 03/26/2018
Postal code
65202-4042
Report date
Apr 4, 2018
Product type
Drugs
Recall number
D-0614-2018
Classification
Class II
Recalling firm
Apollo Care
Product quantity
144 bags
Termination date
May 31, 2018
Reason for recall
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
Distribution pattern
Medical Facility in MO
Recall initiation date
Mar 7, 2018
Initial firm notification
E-Mail
Center classification date
Mar 29, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0614-2018, published Apr 4, 2018. 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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