The Recall Desk

FDA (Drugs) recall action 75212

The Apothecary Shoppe LLC recalled 3 products on 2016-10-12

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
2016-10-12
Critical
0
Units
—

Why these products were recalled

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

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

States named across these recalls

1–3 of 3

  • SevereFDA (Drugs)··2016-10-12

    Apothecary Shoppe Recalls Phenotolamine and Prostaglandin Vials Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling Phenotolamine 0.4mg/Prostaglandin 20mcg/mL vials because they were sterilized with a recalled filter, raising concerns about sterility assurance.

    Product
    Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-10-12

    Methylcobalamin Injection Recalled Due to Sterility Assurance Issues

    The Apothecary Shoppe LLC is recalling Methylcobalamin 5000 mcg/mL Injection in Oklahoma because the medication was sterilized with a recalled filter.

    Product
    Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-10-12

    The Apothecary Shoppe Recalls Tri-Mix 18/1/10 Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling Tri-Mix 18/1/10 vials because the medication was sterilized using a recalled filter, raising concerns about sterility assurance.

    Product
    Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
    Category
    Distribution
    1 state