FDAJanuary 24, 2022drug

SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00

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

UPCs

69103253600

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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