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- Recall Enforcement Event ID: 89334
Recall Enforment Report D-0552-2022
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by ULTRAtab Laboratories, Inc., originally initiated on 01-26-2022 for the product Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00 The product was recalled due to cgmp deviations. The product was distributed in Bulk Product Was Distributed To 3 Distributors Who May Have Distributed Finished Product. and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0552-2022 | 01-26-2022 | 02-16-2022 | Class II | 14,066,434 tablets | Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00 | CGMP Deviations | Terminated |
| D-0540-2022 | 01-26-2022 | 02-16-2022 | Class II | 3,052,313 tablets | Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00 | CGMP Deviations | Terminated |
| D-0550-2022 | 01-26-2022 | 02-16-2022 | Class II | 1,585,375 tablets | Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00 | CGMP Deviations | Terminated |
| D-0545-2022 | 01-26-2022 | 02-16-2022 | Class II | 4,531,580 tablets | Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00 | CGMP Deviations | Terminated |
| D-0530-2022 | 01-26-2022 | 02-16-2022 | Class II | 14,349,148 tablets | APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00 | CGMP Deviations | Terminated |
| D-0534-2022 | 01-26-2022 | 02-16-2022 | Class II | 2,048,941 tablets | Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00 | CGMP Deviations | Terminated |
| D-0532-2022 | 01-26-2022 | 02-16-2022 | Class II | 16,429,211 tablets | Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00 | CGMP Deviations | Terminated |
| D-0546-2022 | 01-26-2022 | 02-16-2022 | Class II | 7,983,360 tablets | Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00 | CGMP Deviations | Terminated |
| D-0542-2022 | 01-26-2022 | 02-16-2022 | Class II | 1,527,203 tablets | Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00 | CGMP Deviations | Terminated |
| D-0529-2022 | 01-26-2022 | 02-16-2022 | Class II | 451,123 tablets | APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00 | CGMP Deviations | Terminated |
| D-0541-2022 | 01-26-2022 | 02-16-2022 | Class II | 3,050,308 tablets | Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00 | CGMP Deviations | Terminated |
| D-0538-2022 | 01-26-2022 | 02-16-2022 | Class II | 50,585,623 tablets | HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00 | CGMP Deviations | Terminated |
| D-0539-2022 | 01-26-2022 | 02-16-2022 | Class II | 3,349,387 tablets | Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00 | CGMP Deviations | Terminated |
| D-0547-2022 | 01-26-2022 | 02-16-2022 | Class II | 990,197 tablets | Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00 | CGMP Deviations | Terminated |
| D-0549-2022 | 01-26-2022 | 02-16-2022 | Class II | 452,038 tablets | Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00 | CGMP Deviations | Terminated |
| D-0524-2022 | 01-26-2022 | 02-16-2022 | Class II | 19,103,287 tablets | 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 | CGMP Deviations | Terminated |
| D-0544-2022 | 01-26-2022 | 02-16-2022 | Class II | 7,297,709 tablets | Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00 | CGMP Deviations | Terminated |
| D-0523-2022 | 01-26-2022 | 02-16-2022 | Class II | 33,758,436 tablets | 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00 | CGMP Deviations | Terminated |
| D-0548-2022 | 01-26-2022 | 02-16-2022 | Class II | 6,380,282 tablets | APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00 | CGMP Deviations | Terminated |
| D-0527-2022 | 01-26-2022 | 02-16-2022 | Class II | 917,304 tablets | Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00 | CGMP Deviations | Terminated |
| D-0555-2022 | 01-26-2022 | 02-16-2022 | Class II | 37,464,418 tablets | Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00 | CGMP Deviations | Terminated |
| D-0537-2022 | 01-26-2022 | 02-16-2022 | Class II | 18,772,640 tablets | APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00 | CGMP Deviations | Terminated |
| D-0553-2022 | 01-26-2022 | 02-16-2022 | Class II | 25,769,495 tablets | Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00 | CGMP Deviations | Terminated |
| D-0543-2022 | 01-26-2022 | 02-16-2022 | Class II | 5,923,518 tablets | Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00 | CGMP Deviations | Terminated |
| D-0525-2022 | 01-26-2022 | 02-16-2022 | Class II | 1,798,048 tablets | Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx | CGMP Deviations | Terminated |
| D-0536-2022 | 01-26-2022 | 02-16-2022 | Class II | 6,249,082 tablets | APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00 | CGMP Deviations | Terminated |
| D-0528-2022 | 01-26-2022 | 02-16-2022 | Class II | 14,566,510 tablets | 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 | CGMP Deviations | Terminated |
| D-0535-2022 | 01-26-2022 | 02-16-2022 | Class II | 6,215,512 tablets | Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00 | CGMP Deviations | Terminated |
| D-0526-2022 | 01-26-2022 | 02-16-2022 | Class II | 639,729 tablets | Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00 | CGMP Deviations | Terminated |
| D-0531-2022 | 01-26-2022 | 02-16-2022 | Class II | 3,677,483 tablets | APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00 | CGMP Deviations | Terminated |
| D-0533-2022 | 01-26-2022 | 02-16-2022 | Class II | 3,667,885 tablets | Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00 | CGMP Deviations | Terminated |
| D-0554-2022 | 01-26-2022 | 02-16-2022 | Class II | 8,727,657 tablets | DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00 | CGMP Deviations | Terminated |
| D-0551-2022 | 01-26-2022 | 02-16-2022 | Class II | 1,477,641 tablets | Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00 | CGMP Deviations | Terminated |
Recall Enforcement Report D-0552-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0552-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 14,066,434 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M785L Bulk Lots: 18K029, 18L059, 18M100, 19B013, 19D024, 19D059, 19E029, 19J050 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0540-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0540-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3,052,313 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M304 Bulk Lots: 18K059, 18L106, 18L117, 18M067, 18M068 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0550-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0550-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,585,375 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M710L Bulk Lots: 19A071 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0545-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0545-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4,531,580 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M333 Bulk Lots: 18M065, 19J078 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0530-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0530-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 14,349,148 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: C140L Bulk Lots: 18K017, 18L002, 19C064, 19E067, 19F064, 19H053, 19J023, 19J051 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0534-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0534-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2,048,941 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: L206L Bulk Lots: 19B002 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0532-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0532-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 16,429,211 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: L202L Bulk Lots: 18K013, 18K014, 18K015, 19A040, 18M076, 19A041, 19H072, 19H073, 19H074 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0546-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0546-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7,983,360 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M338 Bulk Lots: 19A070, 19B080, 19J043 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0542-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0542-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,527,203 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M311 Bulk Lots: 19A069 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0529-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0529-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 451,123 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: C135LA Bulk Lots: 19F077 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0541-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0541-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3,050,308 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M310 Bulk Lots: 19C044, 19H015 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0538-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0538-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 50,585,623 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: L242SRC Bulk Lot: 18K086, 18L009, 18L050, 18L083, 18M025, 18M073, 18M098, 19A010, 19A084, 19A105, 19A107; Product Code: L242L Bulk Lot: 19H014; Product Code: L242PA Bulk Lot: 18F072, 18L119, 19A067, 19G043; Product Code: L242N Bulk Lot: 19H040 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0539-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0539-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3,349,387 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Code: M303 Bulk lots: 19C042, 19C043, 19F083; Product Code: M303A Bulk Lot: 19E105 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0547-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0547-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 990,197 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M565L Bulk Lots: 19F014 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0549-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0549-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 452,038 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M701L Bulk Lots: 19G077 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0524-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0524-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 19,103,287 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Code: C107L Bulk Lots: 18G085, 19B061, 19F066, 19J068 Product Code: C107LB Bulk Lots: 18J051, 18M079, 18M080, 19B017, 19B018, 19C001, 19C081, 19D056, 19D057 Product C107LA: Bulk lots: 19F067 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0544-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0544-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7,297,709 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M320L Bulk Lots: 18M063, 19G076 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0523-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0523-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 33,758,436 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Code C106L; Bulk lots: 18J080, 18L029, 19A103, 19B063, 19D019, 19F065, Product Code C106LA; Bulk lots: 18K045, 18K046, 18L008, 18L105, 19A068, 19A094, 19A106, 19B009, 19C031, 19C032, 19C033, 19G085, 19H070, 19D018, 19H071, 19H082, 19J027 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0548-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0548-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 6,380,282 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M700LA Bulk Lots: 18K037, 18L093, 18M006, 19A121, 19G044, 19G045, 19G046 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0527-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0527-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 917,304 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: C121L Bulk Lots: 19G074, 19G075 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0555-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0555-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 37,464,418 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M945 Bulk Lots: 18J072, 18K030, 18L123, 19A043, 19A093, 19B062, 19C079, 19C080, 19D041, 19E035, 19E087, 19G084, 19H098 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0537-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0537-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 18,772,640 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: L211L Bulk Lots: 18M043, 18M044, 18M045, 19B032, 19B033, 19B034, 19F008, 19F009, 19F010 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0553-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0553-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 25,769,495 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M800L Bulk Lots: 18K005, 18K075, 18K098, 18M064, 19C021, 19C050, 19G081, 19G082, 19H012, 19H013, 19J036, 19J037 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0543-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0543-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5,923,518 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M312 Bulk Lots: 18J004, 18J005, 18C045, 19C046 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0525-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0525-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,798,048 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: C111L Bulk Lot: 18L028 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0536-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0536-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 6,249,082 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: L210L Bulk Lots: 18L120, 19B044, 19E082 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0528-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0528-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 14,566,510 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: C134LC Bulk Lots: 18K055 18M081 19A097 19B024 19C054 19E092 19G094 19J042 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0535-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0535-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 6,215,512 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: L207L Bulk Lots: 18K111, 19E104, 19F050 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0526-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0526-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 639,729 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: C119L Bulk Lots: 18K028 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0531-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0531-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3,677,483 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: L200L Bulk Lots: 18K072, 19C049 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0533-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0533-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3,667,885 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: L203L Bulk Lots: 18K012, 19E091 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0554-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0554-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 8,727,657 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M941L M940LA Bulk Lots: 19C065, 19F081, 19H083, 17D088 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0551-2022
- Event ID
- 89334 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0551-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00
- Reason For Recall
- CGMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,477,641 tablets Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-16-2022
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-07-2025 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Code Info
- Product Codes: M740LA Bulk Lots: 19C022, 19C023 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
