FDAJanuary 24, 2022drug
Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
cGMP deviations
What to do
FDA enforcement status: Terminated
Brands named
ultra sealultra
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASEAL THE SEASONS FROZEN ORGANIC***BLUEBERRIES NET WT. 32 OZ (907g) NC UPC 8 50476 00647 1; NJ UPC 8 50037 94831 ? DISTRIBUTED BY: Seal the Seasons Inc. 4426 S. Miami Blvd. Durham, NC 277032025-06-09
- FDAUltrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system2025-03-31
- CPSCHavertys Recalls Concord Dual Power Recliner Chairs Due to Fall Hazard (Recall Alert)2023-06-22
- FDAProton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra ...2022-08-15
- FDAProton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs,...2022-08-15
- FDASUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.2022-07-21
- FDALite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 334872022-01-24
- FDACold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 750072022-01-24
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