Class I · High risk
Tyenne (tocilizumab-aazg)
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Folic Acid Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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
Affected NDC
63323-0184-11
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Folic Acid NDC 63323-0184 |
5 mg/mL | Injection, Solution Intramuscular|intravenous|subcutaneous |
Fresenius Kabi USA, LLC | Rx |
- Recalling firm
- Fresenius Kabi USA, LLC
- NDC code
- 63323-184-11
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-379-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Fresenius Kabi USA, LLC
All 2013 recalls
Class I · High risk
Morphine Sulfate Injection
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Other impurity / degradation recalls from 2013
All impurity / degradation recalls
Class II · Moderate risk
Hydralazine HCL Tablets
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Class II · Moderate risk
Hydralazine HCL Tablets
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Class III · Low risk
Cetirizine Hydrochloride Syrup
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Class III · Low risk
Ketoconazole Cream
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
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