Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Sub-Potent Drug: Subpotent assay results during stability testing.
Failed Dissolution Specifications.
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Failed Impurity/Degradation Specifications
This recall involves three types of California Gold Nutrition dietary supplements: Daily Prenatal Multi, Ultamins Women's Multivitamin, and Ultamins Women's 50+ Multivitamin. The California Gold Nutrition Daily Prenatal Multivitamin bottles are white with a white lid and a gold border label. The bottle contains 60 fish gelatin softgel dietary supplements. The California Gold Nutrition Women's Multivitamin and Women's 50+ Multivitamin both have dark purple packaging with a gold border label. Both products contain 60 capsules in foil within the packaging. The following batch numbers and expiration dates for the products are printed on the back of the package near the bottom of package/sleeve. Products Batch Codes Expiration Dates Daily Prenatal Multi 2307050A, 2404096A, 2411100A 08/2025, 05/2026, 11/2026 Ultamins Women's Multivitamin V0532, V0533 11/2026, 07/2026 Ultamins Women's 50+ Multivitamin V0534, V0536 07/2026, 11/2026
Downstream recall of a dietary supplement ingredient that was manufactured out of specification.
Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Subpotent Drug: Assay below the approved specification