Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
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not a substitute for professional medical advice or your local public health department's own guidance.
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Every FDA drug enforcement recall Public Health Trace has on record, republished from
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Reports. Newly announced recalls may appear on FDA.gov before they become available in
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Filters
Showing 4,001–4,020 of 17,937 drug recalls
Drug RecallTerminatedHistorical recordClass III
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01
by American Health Packaging
Reason
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
by Plastikon Healthcare LLC
Reason
CGMP Deviations: Failure to properly investigate failed microbial testing.
Recall initiated
March 24, 2022
Reported by FDA
May 25, 2022
Distribution
Distributed in Indiana for further distribution in the USA.
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
by Plastikon Healthcare LLC
Reason
CGMP Deviations: Failure to properly investigate failed microbial testing.
Recall initiated
March 24, 2022
Reported by FDA
May 25, 2022
Distribution
Distributed in Indiana for further distribution in the USA.
Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
by Plastikon Healthcare LLC
Reason
CGMP Deviations: Failure to properly investigate failed microbial testing.
Recall initiated
March 24, 2022
Reported by FDA
May 25, 2022
Distribution
Distributed in Indiana for further distribution in the USA.
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
by Plastikon Healthcare LLC
Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
March 24, 2022
Reported by FDA
May 25, 2022
Distribution
Distributed in Indiana for further distribution in the USA.
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
by Plastikon Healthcare LLC
Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
March 24, 2022
Reported by FDA
May 25, 2022
Distribution
Distributed in Indiana for further distribution in the USA.
Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-07
Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05
Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-04
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
