FDA (Drugs) recall action 83316
The FDA (Drugs) publishes a recall like this one as 18 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 18 pages.
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
US Pharmaceuticals is recalling 880 cases of Adult Glycerin Suppositories because purified water used in manufacturing failed quality tests for microbial count or organic carbon.
US Pharmaceuticals is recalling CVS Therapeutic Menthol Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
US Pharmaceuticals is recalling Kool Comfort Cooling Pain Relief because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
US Pharmaceuticals is recalling Intensive Healing Eczema Lotion due to out-of-specification results for microbial count or organic carbon in the purified water used during manufacturing.
US Pharmaceuticals is recalling CVS Health Glycerin Suppositories due to out-of-specification results for microbial count or organic carbon in the purified water used during manufacturing.
US Pharmaceuticals is recalling 830 tubes of Soothe&Cool Protect Moisture Guard Skin Protectant due to out-of-specification results for microbial count or organic carbon in purified water.
US Pharmaceuticals is recalling 196 cases of Adult Glycerin Suppositories because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
US Pharmaceuticals is recalling 76 cases of Children Glycerin Suppositories due to out-of-specification results in the purified water used during manufacturing.
US Pharmaceuticals is recalling 98 cases of Walgreens Adult Glycerin Suppositories due to out-of-specification results in the purified water used during manufacturing.
US Pharmaceuticals is recalling CRYO-273 Cold Pain Relieving Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
US Pharmaceuticals is recalling specific lots of Maximum Strength Hydrocortisone Cream with Aloe because the purified water used in manufacturing failed quality tests.
US Pharmaceuticals is recalling Wonder Freeze Pain Relieving Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
US Pharmaceuticals is recalling 246 cases of Cool Hot Ice Analgesic Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
US Pharmaceuticals is recalling 651 cases of Maximum Strength Hydrocortisone Cream because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
US Pharmaceuticals is recalling Maximum Strength Hydrocortisone Cream with Aloe due to out-of-specification results in the purified water used during manufacturing.
US Pharmaceuticals is recalling CRYO-273 Cold Pain Relieving Gel Roll-On because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
US Pharmaceuticals is recalling CVS Health Glycerin Suppositories because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
US Pharmaceuticals Inc. is recalling 305 cases of Maximum Strength Hydrocortisone Cream because the purified water used in manufacturing failed quality tests.