Recall Atlas
Drugs & medicalClass I

North American Diagnostics recalls SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML…

Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.

Read the official notice →
Date
2022-08-10
Country
United States
Brand
North American Diagnostics
Product
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand…
Classification
Class I
Units
Worldwide distribution - US Nationwide distribution in the states of FL, LA,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

Other drugs & medical recalls in the United States

  1. 2022-08-10
  2. US
    Drugs & medicalClass II

    Medtronic Inc recalls Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a…

    Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.

    FDA · DeviceMedtronic IncUS Nationwide distribution.Official notice →
  3. US
    Drugs & medicalClass II

    Aesculap Implant Systems LLC recalls PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10

    Endoscopic graspers may become separated at the weld from handle to the shaft of the device.

    FDA · DeviceAesculap Implant Systems LLCUnited States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO,…Official notice →
  4. US
    Drugs & medicalClass II

    MALVERN PANALYTICAL LTD recalls NanoSight NS300

    Product found to not comply to Class 1 Laser safety requirement.

    FDA · DeviceMALVERN PANALYTICAL LTDUS Nationwide - Worldwide DistributionOfficial notice →
  5. US
    Drugs & medicalClass I

    Ultra Supplement LLC recalls SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN…

    Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.

    FDA · DrugUltra Supplement LLCProduct was distributed nationwide in the USA via Amazon Marketplace on…Official notice →
  6. US
    Drugs & medicalClass I

    Distributor RFR, LLC. recalls SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800)…

    Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.

    FDA · DrugDistributor RFR, LLC.Retail stores in the state of FL, Nationwide in the USA, France and Canada via…Official notice →
  7. US
    Drugs & medicalClass III

    Glenmark Pharmaceuticals Inc., USA recalls Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b)…

    Defective Container: Tube split from side seam

    FDA · DrugGlenmark Pharmaceuticals Inc., USANationwide in the USAOfficial notice →
See all drugs & medical recalls →