FDA (Food) recall action 89512
The FDA (Food) publishes a recall like this one as 9 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 9 pages.
cGMP Deviations
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.
ULTRAtab Laboratories has recalled approximately 26.6 million electrolyte tablets due to manufacturing practice deviations. The bulk product was distributed to distributors in New York and Florida.
ULTRAtab Laboratories voluntarily recalled Melatonin ER 5 mg caplets due to manufacturing deviations. The bulk product distributed to wholesalers in New York and Florida may have been repackaged and resold.
ULTRAtab Laboratories is recalling melatonin ER 2 mg caplets due to manufacturing process deviations. The recall affects 5.8 million tablets distributed to wholesalers.
ULTRAtab Laboratories recalls Ephrine Plus dietary supplement tablets due to manufacturing practice deviations. The recall involves 4,250,842 tablets distributed to bulk distributors in New York and Florida.
ULTRAtab Laboratories' caffeine and vitamin B-complex supplement is being recalled due to cGMP (Good Manufacturing Practice) deviations. The voluntary recall affects approximately 1,904,760 tablets distributed to wholesalers.
ULTRAtab Laboratories is voluntarily recalling 1,393,353 caffeine supplement tablets due to manufacturing practice deviations.
ULTRAtab Laboratories voluntarily recalled MidNite Tablet melatonin supplements due to manufacturing practice deviations. The recall encompasses 42,352,387 tablets distributed in bulk to two distributors in New York and Florida.
ULTRAtab Laboratories has recalled 1.6 million tablets of a caffeine and B-vitamin supplement due to manufacturing practice deviations. The bulk product was distributed to distributors in New York and Florida.
ULTRAtab Laboratories is voluntarily recalling approximately 955,928 melatonin ER 0.5 mg caplets due to deviations from FDA manufacturing standards. Bulk product distributed to New York and Florida distributors in 2021.