Folic Acid Injection recall: Impurity Out of Spec
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…
Why was Folic Acid Injection recalled?
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14
- Product
- 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…
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 215,340 vials
- Distribution
- Nationwide, Puerto Rico, Canada, New Zealand
- Recall date
- December 25, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)