Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULT... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc.... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratorie... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, ... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, I... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories,... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Labor... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories,... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bul... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container,... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laborator... Nov 29, 2021 FDA drug enforcement
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Class II Reported terminated
Distribution: Product was distributed to one customer who may have further distributed the product.
Official source for PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets ... Oct 6, 2021 FDA food enforcement
cGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Official source for Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., H... Oct 6, 2021 FDA food enforcement
cGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Official source for Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc.... Oct 6, 2021 FDA food enforcement
cGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Official source for Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY Oct 6, 2021 FDA food enforcement
cGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Official source for Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY Oct 6, 2021 FDA food enforcement
cGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Official source for Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY Oct 6, 2021 FDA food enforcement
cGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Official source for Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY