The Recall Desk

FDA (Drugs) recall action 86171

Eosera, Inc. recalled 4 products on 2020-08-19

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2020-08-19
Critical
0
Units
230,200

Why these products were recalled

cGMP Deviations.

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.

1–4 of 4

  • ModerateFDA (Drugs)··2020-08-19

    Eosera Recalls Ear Pain MD Pain Relief Drops For Kids

    Eosera, Inc. is voluntarily recalling 45,673 bottles of Ear Pain MD Pain Relief Drops For Kids due to cGMP deviations.

    Product
    Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2020-08-19

    Eosera Recalls Ear Itch MD Anti-Itch Spray Due to cGMP Deviations

    Eosera, Inc. is voluntarily recalling 43,424 bottles of Ear Itch MD Anti-Itch Spray due to cGMP deviations. The product was distributed nationwide in the United States.

    Product
    Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2020-08-19

    Eosera Recalls Ear Itch MD Sprays Due to Manufacturing Deviations

    Eosera, Inc. is voluntarily recalling specific lots of Ear Itch MD sprays nationwide due to cGMP deviations.

    Product
    Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2020-08-19

    Eosera Recalls Ear Pain MD Pain Relief Drops Due to cGMP Deviations

    Eosera, Inc. is voluntarily recalling 125,874 bottles of Ear Pain MD Pain Relief Drops with 4% Lidocaine due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0072-2
    Category
    Distribution
    0 states
Eosera, Inc. recalled 4 products on 2020-08-19 · The Recall Desk