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American Laboratories, LLC

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
1
Inspections
12
Compliance Actions
0

Recent Recalls

NumberClassProductDate
H-0611-2026Class IIPepsin 1:10,000 Powder, 10 kg, Item #FTI-G0193-00, American Laboratories 5036 South 33rd Street, OmaFebruary 26, 2026
H-0610-2026Class IIPepsin Full Strength Powder, 50 kg, Item #5000545, American Laboratories 5036 South 33rd Street, OmaFebruary 26, 2026
H-0612-2026Class IIPepsin 1:3000 Powder, 50 kg, Item #FTI-G0193-00, American Laboratories 5036 South 33rd Street, OmahaFebruary 26, 2026
F-0093-2014Class IINUT 14-500, powder, plant enzyme blend, packaged in 15 kg and 23 kg double poly bags inside fiber boSeptember 30, 2013
F-0097-2014Class IIEB 020812-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 77CSeptember 30, 2013
F-0091-2014Class IIXylanase 10,000XU/g, powder, enzyme, 100 gm. Product 45ASeptember 30, 2013
F-0095-2014Class IIUltra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product September 30, 2013
F-0096-2014Class IIEB 110311-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 73CSeptember 30, 2013
F-0094-2014Class IIPC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box. ProSeptember 30, 2013
F-0089-2014Class IIPectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70ASeptember 30, 2013
F-0092-2014Class IIXylanase 70,000XU/g, powder, enzyme, 100 gm. Product 71ASeptember 30, 2013
F-0090-2014Class IIXylanase 150,000XU, powder, enzyme, 100 gm. Product 13ASeptember 30, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K880185DUET (CONDOMS)June 17, 1988