FDAAugust 8, 2019drug
Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
What to do
FDA enforcement status: Terminated
Brands named
alkermes
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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