Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason shortfill; reports of empty capsules.
Reason Presence of Particulate Matter: Hair was found in products
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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