ULTRAtab Laboratories, Inc.
ULTRAtab Laboratories, Inc. appears in FDA public data with 43 recalls, 0 510(k) clearances, 11 FDA inspections, and 2 compliance actions on record. Its most recent recall (D-0534-2022, Class II) was initiated on January 26, 2022.
Summary
- Total Recalls
- 43
- 510(k) Clearances
- 0
- Inspections
- 11
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0534-2022 | Class II | Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highla | January 26, 2022 |
| D-0532-2022 | Class II | Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY | January 26, 2022 |
| D-0546-2022 | Class II | Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, | January 26, 2022 |
| D-0552-2022 | Class II | Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, In | January 26, 2022 |
| D-0540-2022 | Class II | Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highla | January 26, 2022 |
| D-0550-2022 | Class II | Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, In | January 26, 2022 |
| D-0545-2022 | Class II | Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., H | January 26, 2022 |
| D-0530-2022 | Class II | APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTR | January 26, 2022 |
| D-0529-2022 | Class II | APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY | January 26, 2022 |
| D-0541-2022 | Class II | Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highlan | January 26, 2022 |
| D-0538-2022 | Class II | HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Contai | January 26, 2022 |
| D-0539-2022 | Class II | Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Hi | January 26, 2022 |
| D-0547-2022 | Class II | Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., | January 26, 2022 |
| D-0524-2022 | Class II | 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylep | January 26, 2022 |
| D-0544-2022 | Class II | Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAt | January 26, 2022 |
| D-0523-2022 | Class II | 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Contain | January 26, 2022 |
| D-0553-2022 | Class II | Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk C | January 26, 2022 |
| D-0555-2022 | Class II | Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories | January 26, 2022 |
| D-0537-2022 | Class II | APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, | January 26, 2022 |
| D-0525-2022 | Class II | Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTR | January 26, 2022 |