The Recall Desk

FDA (Drugs) recall action 83265

Altaire Pharmaceuticals, Inc. recalled 134 products on 2019-11-27

The FDA (Drugs) publishes a recall like this one as 134 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 134 pages.

Products
134
Announced
2019-11-27
Critical
0
Units
21,639,069

Why these products were recalled

Lack of Assurance of Sterility

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.

51–75 of 134

  • SevereFDA (Drugs)··2019-11-27

    Altaire Recalls OCuSOFT Homatropine Hydrobromide Ophthalmic Solution Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, due to a lack of assurance of sterility. The recall covers 81,403 units distributed nationwide.

    Product
    OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    CVS Lubricant Eye Drops Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility.

    Product
    CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5%, Sensitive Solution, 70 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #457791, NDC 50428 41429 3, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    CVS Health Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Fast Acting Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 58,704 units distributed nationwide.

    Product
    CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882, Product Size: 0.6 mL x 24 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    Altaire Recalls OCuSOFT Eye Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Tears Again Sterile Lubricant Eye Drops because the company cannot guarantee the product's sterility.

    Product
    OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    Altaire Ciprofloxacin Ophthalmic Solution Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling Ciprofloxacin HCL Ophthalmic Solution due to a lack of assurance of sterility. The recall affects 3,060 units distributed nationwide.

    Product
    CIPROFLOXACIN HCL OPHTHALMIC (CIPROFLOXACIN HYDROCHLORIDE)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    Altaire Recalls Equate Sterile Lubricant Stye Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Sterile Lubricant Stye Ointment because the company cannot ensure the product is sterile.

    Product
    Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-875-50
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    OCuSOFT Tears Again Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Tears Again Lubricant Eye Drops due to a lack of assurance of sterility. The recall covers 81,217 units distributed nationwide.

    Product
    OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    Altaire Recalls Neo-Polycin Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Neo-Polycin ophthalmic ointment due to a lack of assurance of sterility. The recall covers 121,572 containers distributed nationwide.

    Product
    Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment Net Wt. 3.5 g, Rx only, Manufactured for Perrigo Minneapolis, MN 55427 NDC 0574-4250-35
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    CVS Health Lubricant Gel Drops Recalled for Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Gel Drops due to a lack of assurance of sterility.

    Product
    CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 634634, Product Size: 0.6 mL x 30, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    Altaire Recalls Nano Tears Lubricant Gel Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling specific lots of Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops because the agency could not ensure the product was sterile.

    Product
    Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-144-51
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    Altaire Recalls Perrigo Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment due to a lack of assurance of sterility.

    Product
    Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    Accutome Rx Accu-WASH Recalled Due to Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling Accutome Rx Accu-WASH eye drops because the product may not be sterile.

    Product
    Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA, Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    CVS Health Lubricant Gel Drops Recalled for Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling CVS Health Extra Strength Lubricant Gel Drops due to a lack of assurance of sterility. The recall affects 159,864 units distributed nationwide.

    Product
    CVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    Altaire Recalls Puralube Petrolatum Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Puralube Petrolatum Ophthalmic Ointment because the company cannot ensure the product is sterile. Consumers should stop using the product and contact their healthcare provider.

    Product
    Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-35
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    Equate Restore Tears Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Restore Tears Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the place of purchase.

    Product
    Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-189-49
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    Altaire Recalls Perrigo Bacitracin Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Perrigo Bacitracin Ophthalmic Ointment because the product lacks assurance of sterility. The recall covers 651,528 units distributed nationwide.

    Product
    Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    CVS Health Lubricating Gel Drops Recalled for Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling CVS Health Lubricating Gel Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the pharmacy.

    Product
    CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    CVS Health Preservative Free Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the pharmacy.

    Product
    CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Item#: 258625 Product Size: 0.6 mL x 60 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-11-27

    CVS Health Lubricant Eye Ointment Recalled for Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling CVS Health Lubricant Eye Ointment Sensitive Formula due to a lack of assurance of sterility.

    Product
    CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2019-11-27

    Altaire Recalls ActivEyes Sterile Altalube Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling ActivEyes Sterile Altalube Ointment because the company cannot guarantee the product is sterile. Consumers should stop using the product and return it to the pharmacy.

    Product
    ALTALUBE (MINERAL OIL AND PETROLATUM)
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2019-11-27

    Altaire Recalls OCuSOFT Ophthalmic Solution Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution because the company cannot guarantee the product is sterile.

    Product
    OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21
    Category
    Distribution
    0 states