The FDA has fi­nal­ized guid­ance to help com­pa­nies quick­ly re­call prod­ucts and take the nec­es­sary steps be­fore a prod­uct reach­es the re­call stage, as part of work pull vi­ola­tive prod­ucts and keep them out of the hands of con­sumers.

Ini­ti­a­tion of Vol­un­tary Re­calls of­fers guid­ance for com­pa­nies to de­vel­op pro­ce­dures in­clud­ing train­ing, plan­ning and record-keep­ing to re­duce the time a dan­ger­ous prod­uct is on the mar­ket and lim­it the risk of ex­po­sure. The FDA can re­call con­trolled sub­stances, bi­o­log­i­cal prod­ucts, hu­man cells, tis­sues and cel­lu­lar and tis­sue-based prod­ucts, as well as med­ical de­vices and food.

The re­port al­so ex­plains how to keep records and prod­uct cod­ing. Since re­calls af­fect the en­tire sup­ply chain, the FDA says that a pro­ce­dure should be in place to quick­ly in­form every­one in line, from down­stream sup­pli­ers to whole­salers and ven­dors. The fi­nal guid­ance builds off of a draft from April 2019.

“Vol­un­tary re­calls con­tin­ue to be the fastest, most ef­fec­tive way for a com­pa­ny to cor­rect or re­move vi­ola­tive and po­ten­tial­ly harm­ful prod­ucts from the mar­ket to help keep con­sumers safe,” said Ju­dith McMeekin, the FDA’s as­so­ciate com­mis­sion­er of reg­u­la­to­ry af­fairs. “It is crit­i­cal that all com­pa­nies in the sup­ply chain are ‘re­call ready’ to en­sure ap­pro­pri­ate ac­tions are tak­en swift­ly across the dis­tri­b­u­tion chan­nels to best pro­tect pub­lic health and the in­tegri­ty of the sup­ply chain. We will con­tin­ue to work with com­pa­nies to im­prove their re­call pro­ce­dures and min­i­mize Amer­i­cans’ ex­po­sure to po­ten­tial­ly harm­ful prod­ucts.”

There have been 14 drugs re­called since the start of 2022 alone, ac­cord­ing to the FDA’s web­site. Most re­cent­ly, Braun Med­ical was forced to vol­un­tar­i­ly re­call five lots of its 0.9% Sodi­um Chlo­ride for In­jec­tion USP 250ML due to flu­id leak­age or low fill vol­ume. That re­call was an­nounced Thurs­day.

In 2021, there were 77 drugs re­called. Most no­tably was the in­dus­try’s is­sues with ND­MA con­t­a­m­i­na­tion, a known prob­a­ble hu­man car­cino­gen with can­cer-caus­ing po­ten­tial.

In Jan­u­ary, Viona Phar­ma­ceu­ti­cals re­called 33 lots of met­formin hy­drochlo­ride af­ter find­ing traces of ND­MA. But Pfiz­er bat­tled is­sues with the con­t­a­m­i­na­tion of its an­ti-smok­ing drug Chan­tix in June, Ju­ly, Au­gust and Sep­tem­ber for ND­MA. Lots were dis­trib­uted in the US, US Vir­gin Is­lands and Puer­to Ri­co from May 2019 to Sep­tem­ber 2021. In 2018, blood pres­sure drug val­sar­tan was pulled for the same rea­son. Last Jan­u­ary, Nos­trum Lab­o­ra­to­ries twice vol­un­tar­i­ly re­called its gener­ic met­formin. In No­vem­ber 2020, a batch of 500 mg tablets was re­called for the same rea­son.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.