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ULTRAtab Laboratories, Inc. FDA Recalls
43 recalls on file across drugs, food, 0 of them Class I and 0 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULClass IIJan 26, 2022CGMP Deviations |
| Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab LaboratClass IIJan 26, 2022CGMP Deviations |
| Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310Class IIJan 26, 2022CGMP Deviations |
| Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDClass IIJan 26, 2022CGMP Deviations |
| DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories,Class IIJan 26, 2022CGMP Deviations |
| Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-30Class IIJan 26, 2022CGMP Deviations |
| 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab LaboratClass IIJan 26, 2022CGMP Deviations |
| Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC Class IIJan 26, 2022CGMP Deviations |
| APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00Class IIJan 26, 2022CGMP Deviations |
| APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDCClass IIJan 26, 2022CGMP Deviations |
| Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, IClass IIJan 26, 2022CGMP Deviations |
| APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00Class IIJan 26, 2022CGMP Deviations |
| Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab LClass IIJan 26, 2022CGMP Deviations |
| Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 6295Class IIJan 26, 2022CGMP Deviations |
| Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62Class IIJan 26, 2022CGMP Deviations |
| 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Class IIJan 26, 2022CGMP Deviations |
| APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-0Class IIJan 26, 2022CGMP Deviations |
| APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, IClass IIJan 26, 2022CGMP Deviations |
| HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab LaboraClass IIJan 26, 2022CGMP Deviations |
| APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00Class IIJan 26, 2022CGMP Deviations |
| Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDClass IIJan 26, 2022CGMP Deviations |
| Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62Class IIJan 26, 2022CGMP Deviations |
| Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, IncClass IIJan 26, 2022CGMP Deviations |
| Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 629Class IIJan 26, 2022CGMP Deviations |
| Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., HighlandClass IIJan 26, 2022CGMP Deviations |
| Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62Class IIJan 26, 2022CGMP Deviations |
| Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00Class IIJan 26, 2022CGMP Deviations |
| Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY Class IIJan 26, 2022CGMP Deviations |
| Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206Class IIJan 26, 2022CGMP Deviations |
| Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00Class IIJan 26, 2022CGMP Deviations |
| Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959Class IIJan 26, 2022CGMP Deviations |
| Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NYClass IIJan 26, 2022CGMP Deviations |
| Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc.Class IIJan 26, 2022CGMP Deviations |
| PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated Class IINov 29, 2021CGMP Deviations: failed stability results, inadequate labora |
| Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NYClass IIOct 6, 2021cGMP Deviations |
| Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NYClass IIOct 6, 2021cGMP Deviations |
| Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NYClass IIOct 6, 2021cGMP Deviations |
| Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NYClass IIOct 6, 2021cGMP Deviations |
| Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NYClass IIOct 6, 2021cGMP Deviations |
| Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NYClass IIOct 6, 2021cGMP Deviations |
| Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NYClass IIOct 6, 2021cGMP Deviations |
| MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NYClass IIOct 6, 2021cGMP Deviations |
| Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NYClass IIOct 6, 2021cGMP Deviations |