Recall archive
61 recalls · page 3 of 3
Reported Jun 10, 2015
KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free],…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
FDA (openFDA drug enforcement)
Reported Feb 4, 2015
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand · Product details — The lot failed pH specification.
FDA (openFDA device enforcement)
Reported Dec 17, 2014
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand — Defective Container: Vials may be missing stoppers.
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Nov 19, 2014
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Kabi USA LLC
Matched: Brand · Product · Product details · Reason for recall — Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an…
FDA (openFDA drug enforcement)
Reported Aug 27, 2014
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand — CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API…
FDA (openFDA drug enforcement)
Reported Jul 16, 2014
Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Mar 12, 2014
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand — Subpotent; 18 month time point
FDA (openFDA drug enforcement)
Reported Jan 29, 2014
Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
FDA (openFDA drug enforcement)
Reported Dec 25, 2013
FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Kabi USA, LLC
Matched: Brand — Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
FDA (openFDA drug enforcement)
Reported Dec 4, 2013
PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only;…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Kabi USA, LLC
Matched: Brand — Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
FDA (openFDA drug enforcement)
Reported Sep 4, 2013
Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand — Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
FDA (openFDA drug enforcement)
Reported Jul 24, 2013
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand — Subpotent Drug; 15-month stability test station
FDA (openFDA drug enforcement)
Reported Jul 17, 2013
Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed…
1 more product in this recall
FDA (openFDA drug enforcement)
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