The Recall Desk

FDA (Drugs) recall action 82089

Advanced Pharma Inc. recalled 3 products on 2019-02-27

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-02-27
Critical
0
Units
2,144

Why these products were recalled

Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Drugs)··2019-02-27

    Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotency

    Advanced Pharma Inc. is recalling 672 bags of Oxytocin 20 Units Injectable Solution because the product may contain higher concentrations than labeled.

    Product
    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.
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2019-02-27

    Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotent Drug Concerns

    Advanced Pharma Inc. is recalling 12 bags of Oxytocin 10 Units Injectable Solution because the product may contain higher concentrations than labeled.

    Product
    Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-02-27

    Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotency

    Advanced Pharma Inc. is recalling Oxytocin 30 Units Injectable Solution because the product may contain higher concentrations than labeled.

    Product
    Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.
    Category
    Distribution
    0 states