Highland, NY, United States
ULTRAtab Laboratories, Inc. recalls
3 recalls recorded since 2018, most recently on 26 January 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 26 January 2022
- Terminated
- 7 January 2025
- Reason
- CGMP Deviations
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0536-2022, D-0547-2022, D-0528-2022, D-0541-2022, D-0552-2022, D-0540-2022, D-0549-2022, D-0524-2022, D-0538-2022, D-0553-2022, D-0539-2022, D-0554-2022 and 21 more
- APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
- Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00
- Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
- Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00
- Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
- Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00
- Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00
- 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00
- and 25 more product lines
Terminated Class II Drugs
- Recall started
- 29 November 2021
- Terminated
- 24 February 2023
- Reason
- CGMP Deviations: failed stability results, inadequate laboratory investigations,
- Distribution
- Product was distributed to one customer who may have further distributed the product.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0327-2022
- PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product
Terminated Class II Food
- Recall started
- 6 October 2021
- Terminated
- 1 September 2022
- Reason
- cGMP Deviations
- Distribution
- Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- F-0722-2022, F-0729-2022, F-0728-2022, F-0727-2022, F-0724-2022, F-0721-2022, F-0723-2022, F-0726-2022, F-0725-2022
- Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
- MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY
- Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY
- Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- and 1 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.