Recall archive
10 recalls · page 1 of 1
Reported May 8, 2019
HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advanced Pharma Inc.
Matched: Brand — Sub-potency
FDA (openFDA drug enforcement)
Reported Mar 27, 2019
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advanced Pharma Inc.
Matched: Brand — Lack of Assurance of Sterility
18 more products in this recall
FDA (openFDA drug enforcement)
Reported Feb 27, 2019
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advanced Pharma Inc.
Matched: Brand — Labeling: Incorrect expiration date.
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 30, 2019
HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advanced Pharma Inc.
Matched: Brand — Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate…
FDA (openFDA drug enforcement)
Reported Jan 2, 2019
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Advanced Pharma Inc.
Matched: Brand — Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100…
FDA (openFDA drug enforcement)
Reported Jul 4, 2018
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advanced Pharma Inc.
Matched: Brand · Product · Product details — Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
FDA (openFDA drug enforcement)
Reported Jan 31, 2018
MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Advanced Pharma Inc.
Matched: Brand — Subpotent
FDA (openFDA drug enforcement)
Reported Dec 27, 2017
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Advanced Pharma Inc.
Matched: Brand · Product details — Subpotent Drug: found to be below the specification for labeled assay.
6 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 19, 2017
QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advanced Pharma Inc.
Matched: Brand · Product details — Lack of Assurance of Sterility
3 more products in this recall
FDA (openFDA drug enforcement)
Reported May 31, 2017
Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Advanced Pharma Inc.
Matched: Brand — Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
59 more products in this recall
FDA (openFDA drug enforcement)
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