CVS, Walgreen Suspend OTC Ranitidine Sales As FDA Investigates Contamination

CVS, Walgreen suspend sales of brand and store brand ranitidine OTCs while Sanofi confirms it is not recalling Zantac in the US and has no plans to cease manufacturing or distributing.

CVS Storefront

CVS Health Corp. and Walgreen Co.aren’t waiting for the US Food and Drug Administration to complete its investigation of a potential carcinogenic contamination of ranitidine as the US drug store chains suspend sales of OTC Zantac and their store brand equivalents.

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Perrigo’s Formula To Drive Earnings Rebound Swings On Further Formula Business Recovery

 

“The infant formula business is recovering and we've taken actions to simplify and consumerize our business, but there's a lot more work to do,” says CEO Patrick Lockwood-Taylor as Perrigo’s announced latest results.

Nozzle At Tip Of Problems For Florida Eye Drop Firm: US FDA Warns Of GMP, Monograph Violations

 

Regenerative Processing replaces nozzle to prevent backflow for its Regener-Eyes drops but FDA warning states numerous questions about sterility at the firm’s plant and about its procedures and systems for preventing microbial contamination.

Reporting Problems To US FDA Simplified After Delayed Response To Formula Plant Complaint

 

Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”

Different Name, Same Contamination, Recall Problems For US Homeopathic Nasal Spray Firm

 

Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.

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US FDA Principal Deputy Commissioner Bumpus Leaving At Year’s End, Creating Leadership Void

 
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Namandje Bumpus' departure means there is no obvious, internal candidate to serve as acting commissioner when President-elect Donald Trump takes office in January and the Senate works to confirm a new leader.

OTC ACNU Final Rule Publication In December Included In US FDA’s Latest Regulatory Goals List

 

Latest regulatory goals update also includes April as target date for final rule on exemptions from IND clearance for clinical trials to evaluate food, dietary supplements or cosmetics and May for an NPRM would recognize N-acetyl-L-cysteine as a lawful dietary ingredient.

France Reverse-Switches Pseudoephedrine OTCs Over Long-Running Safety Concerns

 
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Oral pseudoephedrine decongestants marketed by Kenuve, Haleon and Opella, amongst others, are now only available with a doctor's prescription in France.