FDA (Drugs) recall action 98239
The FDA (Drugs) publishes a recall like this one as 27 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 27 pages.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
The agency’s own wording, quoted from the enforcement report.
AZ Gems is recalling 1,099 cases of Member's Mark Jumbo Raw Shrimp over elevated levels of chloramphenicol.
Gold Star Distribution is recalling Carmex over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Medline is recalling 1725 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Repligen is recalling 33 MAVERICK Measurement Module Spectrometers because cable faults can drive laser output to about 1,600 mW or falsely signal a fire command.
Gold Star Distribution is recalling Petroleum jelly over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Heraeus Medical is recalling PALACOS MV+G pro 40 and PALACOS MV+G pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.
Gusto Group is recalling 7 cases of Klong Kone shrimp paste after the product tested high for lead.
Eureka Inc is recalling 32 cases of ground cinnamon in 100g clear plastic containers over elevated levels of lead.
Gold Star Distribution is recalling Personal Care Ice Gel over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling Claritin over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling Benadryl over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling Aleve over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling Deodorant products over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling Halls Cough Drops across multiple flavours over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling Tylenol over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling Liquid NyQuil over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Diagnostica Stago is recalling 438 Asserachrom HPIA kits from one lot because a potential defect can affect every well in an impacted strip and produce negative results.
Gold Star Distribution is recalling Pepcid Complete over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling DayQuil Cold and Flu over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling Liquid DayQuil over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling NyQuil Cold and Flu over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling Excedrin Migraine over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling TUMS antacid tablets over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
GE Medical Systems Israel is recalling 38 MAXXUS systems because units past end of guaranteed service may have been moved without adequate detector support, risking a detector fall.
Gold Star Distribution is recalling Excedrin over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.