FDAAugust 9, 2022device
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
What to do
FDA enforcement status: Ongoing
Brands named
jiangsu well biotechjiangsujiangsu well
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAKetamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.2026-04-01
- FDAfentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.2026-04-01
- FDAfentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.2026-04-01
- FDAfentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.2026-04-01
- FDAPhenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-032026-04-01
- FDAfentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.2026-04-01
- FDAfentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.2026-04-01
- FDARaw & Unfiltered Bee Well Wildflower Honey NET wT. 12 OZ (340g) UPC 8 32587 00003 2, NET WT. 22 OZ (624g) UPC 8 32587 00002 5 & NET WT. 44 OZ (1.25g) UPC 8 32587 00001 8 100% Pure Honey Bee Well Honey 909 W. Main Street Pickens, SC 296712026-03-20
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