Multi-event January 2022 FDA Recall Drug by Ultratab Laboratories, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Ultratab Laboratories, Inc. on January 26, 2022 for the product Drug. The FDA reported the reason for recall as 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.

Reported Recall Events

D-0534-2022 TERMINATED D-0532-2022 TERMINATED D-0546-2022 TERMINATED D-0542-2022 TERMINATED D-0552-2022 TERMINATED D-0540-2022 TERMINATED D-0550-2022 TERMINATED D-0545-2022 TERMINATED D-0530-2022 TERMINATED D-0529-2022 TERMINATED D-0541-2022 TERMINATED D-0538-2022 TERMINATED D-0539-2022 TERMINATED D-0547-2022 TERMINATED D-0549-2022 TERMINATED D-0524-2022 TERMINATED D-0544-2022 TERMINATED D-0553-2022 TERMINATED D-0523-2022 TERMINATED D-0543-2022 TERMINATED D-0548-2022 TERMINATED D-0525-2022 TERMINATED D-0527-2022 TERMINATED D-0555-2022 TERMINATED D-0537-2022 TERMINATED D-0536-2022 TERMINATED D-0528-2022 TERMINATED D-0535-2022 TERMINATED D-0526-2022 TERMINATED D-0531-2022 TERMINATED D-0533-2022 TERMINATED D-0554-2022 TERMINATED D-0551-2022 TERMINATED

Recall Number: D-0534-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
2,048,941 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00

Batch or Lot Expiration Information

Lot# Product Codes: L206L Bulk Lots: 19B002

Recall Number: D-0532-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
16,429,211 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00

Batch or Lot Expiration Information

Lot# Product Codes: L202L Bulk Lots: 18K013, 18K014, 18K015, 19A040, 18M076, 19A041, 19H072, 19H073, 19H074

Recall Number: D-0546-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
7,983,360 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00

Batch or Lot Expiration Information

Lot# Product Codes: M338 Bulk Lots: 19A070, 19B080, 19J043

Recall Number: D-0542-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
1,527,203 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00

Batch or Lot Expiration Information

Lot# Product Codes: M311 Bulk Lots: 19A069

Recall Number: D-0552-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
14,066,434 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00

Batch or Lot Expiration Information

Lot# Product Codes: M785L Bulk Lots: 18K029, 18L059, 18M100, 19B013, 19D024, 19D059, 19E029, 19J050

Recall Number: D-0540-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
3,052,313 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00

Batch or Lot Expiration Information

Lot# Product Codes: M304 Bulk Lots: 18K059, 18L106, 18L117, 18M067, 18M068

Recall Number: D-0550-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
1,585,375 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00

Batch or Lot Expiration Information

Lot# Product Codes: M710L Bulk Lots: 19A071

Recall Number: D-0545-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
4,531,580 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00

Batch or Lot Expiration Information

Lot# Product Codes: M333 Bulk Lots: 18M065, 19J078

Recall Number: D-0530-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
14,349,148 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00

Batch or Lot Expiration Information

Lot# Product Codes: C140L Bulk Lots: 18K017, 18L002, 19C064, 19E067, 19F064, 19H053, 19J023, 19J051

Recall Number: D-0529-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
451,123 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00

Batch or Lot Expiration Information

Lot# Product Codes: C135LA Bulk Lots: 19F077

Recall Number: D-0541-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
3,050,308 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00

Batch or Lot Expiration Information

Lot# Product Codes: M310 Bulk Lots: 19C044, 19H015

Recall Number: D-0538-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
50,585,623 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-0539-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
3,349,387 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00

Batch or Lot Expiration Information

Lot# Product Code: M303 Bulk lots: 19C042, 19C043, 19F083; Product Code: M303A Bulk Lot: 19E105

Recall Number: D-0547-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
990,197 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00

Batch or Lot Expiration Information

Lot# Product Codes: M565L Bulk Lots: 19F014

Recall Number: D-0549-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
452,038 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00

Batch or Lot Expiration Information

Lot# Product Codes: M701L Bulk Lots: 19G077

Recall Number: D-0524-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
19,103,287 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-0544-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
7,297,709 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00

Batch or Lot Expiration Information

Lot# Product Codes: M320L Bulk Lots: 18M063, 19G076

Recall Number: D-0553-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
25,769,495 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Product Codes: M800L Bulk Lots: 18K005, 18K075, 18K098, 18M064, 19C021, 19C050, 19G081, 19G082, 19H012, 19H013, 19J036, 19J037

Recall Number: D-0523-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
33,758,436 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-0543-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
5,923,518 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00

Batch or Lot Expiration Information

Lot# Product Codes: M312 Bulk Lots: 18J004, 18J005, 18C045, 19C046

Recall Number: D-0548-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
6,380,282 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00

Batch or Lot Expiration Information

Lot# Product Codes: M700LA Bulk Lots: 18K037, 18L093, 18M006, 19A121, 19G044, 19G045, 19G046

Recall Number: D-0525-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
1,798,048 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx

Batch or Lot Expiration Information

Lot# Product Codes: C111L Bulk Lot: 18L028

Recall Number: D-0527-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
917,304 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00

Batch or Lot Expiration Information

Lot# Product Codes: C121L Bulk Lots: 19G074, 19G075

Recall Number: D-0555-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
37,464,418 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00

Batch or Lot Expiration Information

Lot# Product Codes: M945 Bulk Lots: 18J072, 18K030, 18L123, 19A043, 19A093, 19B062, 19C079, 19C080, 19D041, 19E035, 19E087, 19G084, 19H098

Recall Number: D-0537-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
18,772,640 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00

Batch or Lot Expiration Information

Lot# Product Codes: L211L Bulk Lots: 18M043, 18M044, 18M045, 19B032, 19B033, 19B034, 19F008, 19F009, 19F010

Recall Number: D-0536-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
6,249,082 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00

Batch or Lot Expiration Information

Lot# Product Codes: L210L Bulk Lots: 18L120, 19B044, 19E082

Recall Number: D-0528-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
14,566,510 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Product Codes: C134LC Bulk Lots: 18K055 18M081 19A097 19B024 19C054 19E092 19G094 19J042

Recall Number: D-0535-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
6,215,512 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00

Batch or Lot Expiration Information

Lot# Product Codes: L207L Bulk Lots: 18K111, 19E104, 19F050

Recall Number: D-0526-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
639,729 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Product Codes: C119L Bulk Lots: 18K028

Recall Number: D-0531-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
3,677,483 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00

Batch or Lot Expiration Information

Lot# Product Codes: L200L Bulk Lots: 18K072, 19C049

Recall Number: D-0533-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
3,667,885 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00

Batch or Lot Expiration Information

Lot# Product Codes: L203L Bulk Lots: 18K012, 19E091

Recall Number: D-0554-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
8,727,657 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Product Codes: M941L M940LA Bulk Lots: 19C065, 19F081, 19H083, 17D088

Recall Number: D-0551-2022

Reason for Recall
CGMP Deviations
Initiated
01-26-2022
Reported
02-16-2022
Quantity
1,477,641 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89334
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ULTRAtab Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Bulk product was distributed to 3 distributors who may have distributed finished product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-07-2025
Product Description About Product Description
Full technical description of the product.
Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00

Batch or Lot Expiration Information

Lot# Product Codes: M740LA Bulk Lots: 19C022, 19C023