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Class III: unlikely to cause harmTerminated

Fresenius Kabi Folic Acid Injection Recall

FOLIC ACID INJECTION, USP

Fresenius Kabi USA, LLC · Lake Zurich, IL

Risk level
Class III
Reported by FDA
Dec 25, 2013
Recall ID
D-379-2014
Check your lot numberHow we source this data

Summary

Fresenius Kabi recalled Folic Acid Injection starting Dec 6, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-379-2014 on Dec 25, 2013. Reason: Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point

Product description

FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11

Lot numbers, UPCs & expiration codes

Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14

Where it was sold

Nationwide, Puerto Rico, Canada, New Zealand

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-379-2014
Classification
Class III
Status
Terminated
Recall initiated
Dec 6, 2013
FDA report date
Dec 25, 2013
Quantity
215,340 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Fresenius Kabi USA, LLC

Original FDA data

Every field from FDA enforcement report D-379-2014, exactly as published.

Show all FDA fields
City
Lake Zurich
State
IL
Status
Terminated
Country
United States
Event ID
67054
Address
3 Corporate Dr
Code information
Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14
Postal code
60047-8930
Report date
Dec 25, 2013
Product type
Drugs
Recall number
D-379-2014
Classification
Class III
Recalling firm
Fresenius Kabi USA, LLC
Product quantity
215,340 vials
Termination date
May 21, 2015
Reason for recall
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Voluntary / mandated
Voluntary: Firm initiated
Product description
FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11
Distribution pattern
Nationwide, Puerto Rico, Canada, New Zealand
Recall initiation date
Dec 6, 2013
Initial firm notification
Letter
Center classification date
Dec 18, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-379-2014, published Dec 25, 2013. 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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