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Every FDA drug enforcement recall Public Health Trace has on record, republished from
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Showing 8,901–8,920 of 17,964 drug recalls
Drug RecallTerminatedHistorical recordClass I
Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3.
by Epic Products, LLC
Reason
Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan, encapsulated in the United States. NDC 64764-080-60
by Takeda Development Center Americas, Inc.
Reason
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Recall initiated
November 6, 2018
Reported by FDA
November 21, 2018
Distribution
Product was distributed to 32 distributors throughout the United States.
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540
Non-Sterility: Product manufactured under non-sterile production conditions.
Recall initiated
November 5, 2018
Reported by FDA
November 21, 2018
Distribution
Product was distributed via online stores and retail distributors Nationwide in the USA, Uruguay, Canada, China, Dominican Republic, Korea, and Vietnam.
ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ 08876 USA. NDC: 66733-958-23
by Eli Lilly & Co
Reason
Labeling: Missing label; potential for missing primary container label on the vial.
Recall initiated
November 8, 2018
Reported by FDA
November 21, 2018
Distribution
AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
by Teva Pharmaceuticals USA
Reason
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Recall initiated
September 27, 2018
Reported by FDA
November 21, 2018
Distribution
Product was distributed throughout the United States, including Hawaii and Puerto Rico.
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.
