Multi-event May 2019 FDA Recall Drug by Geritrex, Llc

This Multi-event Class II drug recall was voluntarily initiated by Geritrex, Llc on May 31, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1526-2019 TERMINATED D-1521-2019 TERMINATED D-1520-2019 TERMINATED D-1523-2019 TERMINATED D-1522-2019 TERMINATED D-1527-2019 TERMINATED D-1524-2019 TERMINATED D-1525-2019 TERMINATED

Recall Number: D-1526-2019

Reason for Recall
cGMP Deviations: Products may have microbial contamination.
Initiated
05-31-2019
Reported
07-31-2019
Quantity
6213 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83200
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.
Geritrex, LLC
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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-02-2024
Product Description About Product Description
Full technical description of the product.
Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16

Batch or Lot Expiration Information

Lot# : 70602, Exp 6/19

Recall Number: D-1521-2019

Reason for Recall
cGMP Deviations: Products may have microbial contamination.
Initiated
05-31-2019
Reported
07-31-2019
Quantity
5107 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83200
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.
Geritrex, LLC
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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-02-2024
Product Description About Product Description
Full technical description of the product.
Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-04

Batch or Lot Expiration Information

Lot# : 70602, Exp 6/19

Recall Number: D-1520-2019

Reason for Recall
cGMP Deviations: Products may have microbial contamination.
Initiated
05-31-2019
Reported
07-31-2019
Quantity
8645 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83200
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.
Geritrex, LLC
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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-02-2024
Product Description About Product Description
Full technical description of the product.
Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04

Batch or Lot Expiration Information

Lot# : 70606, Exp 6/19

Recall Number: D-1523-2019

Reason for Recall
cGMP Deviations: Products may have microbial contamination.
Initiated
05-31-2019
Reported
07-31-2019
Quantity
3789 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83200
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.
Geritrex, LLC
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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-02-2024
Product Description About Product Description
Full technical description of the product.
Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16

Batch or Lot Expiration Information

Lot# : 70601, Exp 6/19

Recall Number: D-1522-2019

Reason for Recall
cGMP Deviations: Products may have microbial contamination.
Initiated
05-31-2019
Reported
07-31-2019
Quantity
6165 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83200
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.
Geritrex, LLC
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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-02-2024
Product Description About Product Description
Full technical description of the product.
Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-403-16

Batch or Lot Expiration Information

Lot# : 70612, Exp 6/19

Recall Number: D-1527-2019

Reason for Recall
cGMP Deviations: Products may have microbial contamination.
Initiated
05-31-2019
Reported
07-31-2019
Quantity
15435 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83200
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.
Geritrex, LLC
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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-02-2024
Product Description About Product Description
Full technical description of the product.
Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Corp. 40 Commercial Avenue Middletown, NY 10941, Distributed by Kinray Inc. Whitestone, NY 11357, NDC 53807-216-16

Batch or Lot Expiration Information

Lot# : 70603, 70604, 70612, Exp 6/19

Recall Number: D-1524-2019

Reason for Recall
cGMP Deviations: Products may have microbial contamination.
Initiated
05-31-2019
Reported
07-31-2019
Quantity
3864 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83200
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.
Geritrex, LLC
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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-02-2024
Product Description About Product Description
Full technical description of the product.
Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 52807-177-16

Batch or Lot Expiration Information

Lot# : 70601, Exp 6/19

Recall Number: D-1525-2019

Reason for Recall
cGMP Deviations: Products may have microbial contamination.
Initiated
05-31-2019
Reported
07-31-2019
Quantity
7653 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83200
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.
Geritrex, LLC
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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-02-2024
Product Description About Product Description
Full technical description of the product.
Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941

Batch or Lot Expiration Information

Lot# : 70611, Exp 6/19