The Recall Desk

FDA (Drugs) recall action 79420

American Pharmaceutical Ingredients LLC recalled 2 products on 2018-03-21

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2018-03-21
Critical
0
Units
1,481

Why these products were recalled

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

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.

1–2 of 2

  • ModerateFDA (Drugs)··2018-03-21

    American Pharmaceutical Ingredients Recalls Sermorelin Acetate Powder Due to Stability Data

    American Pharmaceutical Ingredients LLC is recalling Sermorelin Acetate powder because stability data does not support the listed expiration dates.

    Product
    Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-03-21

    Oxytocin USP Powder Recalled Due to Insufficient Stability Data

    American Pharmaceutical Ingredients LLC is recalling Oxytocin USP powder because stability data does not support the listed expiration dates.

    Product
    Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
    Category
    Distribution
    0 states