Multi-event May 2018 FDA Recall Senna Syrup by Rij Pharmaceutical Llc

This Multi-event Class II drug recall was voluntarily initiated by Rij Pharmaceutical Llc on May 7, 2018 for the product Senna Syrup. 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-0845-2018 TERMINATED D-0843-2018 TERMINATED D-0850-2018 TERMINATED D-0853-2018 TERMINATED D-0849-2018 TERMINATED D-0846-2018 TERMINATED D-0842-2018 TERMINATED D-0847-2018 TERMINATED D-0844-2018 TERMINATED D-0848-2018 TERMINATED D-0852-2018 TERMINATED D-0851-2018 TERMINATED

Recall Number: D-0845-2018

Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Initiated
05-07-2018
Reported
06-20-2018
Quantity
1272 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80053
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.
RIJ Pharmaceutical 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-07-2023
Product Description About Product Description
Full technical description of the product.
RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 53807-129-04, UPC 353807129048

Batch or Lot Expiration Information

Lot# : 47080091, Exp. 08/19

Recall Number: D-0843-2018

Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Initiated
05-07-2018
Reported
06-20-2018
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80053
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.
RIJ Pharmaceutical 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-07-2023
Product Description About Product Description
Full technical description of the product.
Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ. (355 mL) bottles, Manufactured By: RIJ PHARMACEUTICAL CORPORATION 40 Commercial Avenue Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357, NDC 53807-12612, UPC 53807126122

Batch or Lot Expiration Information

Lot# : 707006, Exp. 07/19; 708001, Exp. 08/19

Recall Number: D-0850-2018

Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Initiated
05-07-2018
Reported
06-20-2018
Quantity
31411 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80053
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.
RIJ Pharmaceutical 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-07-2023
Product Description About Product Description
Full technical description of the product.
Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088

Batch or Lot Expiration Information

Lot# : 47060011, 47070031, 47070041, Exp. 09/18; 47080031, Exp.10/18

Recall Number: D-0853-2018

Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Initiated
05-07-2018
Reported
06-20-2018
Quantity
8124 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80053
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.
RIJ Pharmaceutical 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-07-2023
Product Description About Product Description
Full technical description of the product.
Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167

Batch or Lot Expiration Information

Lot# : 4780111, Exp. 08/19

Recall Number: D-0849-2018

Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Initiated
05-07-2018
Reported
06-20-2018
Quantity
9240 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80053
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.
RIJ Pharmaceutical 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-07-2023
Product Description About Product Description
Full technical description of the product.
Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ PHARMACEUTICAL CORPORATION 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 5380740904, UPC 35380740941

Batch or Lot Expiration Information

Lot# : 47070021, Exp. 07/19

Recall Number: D-0846-2018

Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Initiated
05-07-2018
Reported
06-20-2018
Quantity
13380 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80053
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.
RIJ Pharmaceutical 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-07-2023
Product Description About Product Description
Full technical description of the product.
Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 5789618016, UPC 357896180164

Batch or Lot Expiration Information

Lot# : 47080081, 47080093, Exp. 08/19

Recall Number: D-0842-2018

Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Initiated
05-07-2018
Reported
06-20-2018
Quantity
5043 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80053
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.
RIJ Pharmaceutical 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-07-2023
Product Description About Product Description
Full technical description of the product.
Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL. OZ. (355 mL), Manufactured By: RIJ Pharmaceutical Corp.40 Commercial Avenue, Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357 NDC 53807-158-12, UPC 353807158123

Batch or Lot Expiration Information

Lot# : 707007, Exp. 07/19

Recall Number: D-0847-2018

Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Initiated
05-07-2018
Reported
06-20-2018
Quantity
228 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80053
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.
RIJ Pharmaceutical 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-07-2023
Product Description About Product Description
Full technical description of the product.
RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY, NDC 53807-129-16, UPC 353807129161

Batch or Lot Expiration Information

Lot# : 47080092, Exp 08/19

Recall Number: D-0844-2018

Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Initiated
05-07-2018
Reported
06-20-2018
Quantity
1505 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80053
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.
RIJ Pharmaceutical 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-07-2023
Product Description About Product Description
Full technical description of the product.
RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080

Batch or Lot Expiration Information

Lot# : 47070081, Exp 09/18

Recall Number: D-0848-2018

Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Initiated
05-07-2018
Reported
06-20-2018
Quantity
21213 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80053
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.
RIJ Pharmaceutical 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-07-2023
Product Description About Product Description
Full technical description of the product.
GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087

Batch or Lot Expiration Information

Lot# : 47070082, 47070043, 47070011, Exp. 09/18

Recall Number: D-0852-2018

Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Initiated
05-07-2018
Reported
06-20-2018
Quantity
12756 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80053
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.
RIJ Pharmaceutical 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-07-2023
Product Description About Product Description
Full technical description of the product.
Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street, Brooklyn, NY 11204, NDC 57896-403-16, UPC 357896-403164,

Batch or Lot Expiration Information

Lot# : 47080041, 47080051, Exp. 08/19

Recall Number: D-0851-2018

Reason for Recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Initiated
05-07-2018
Reported
06-20-2018
Quantity
3537 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80053
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.
RIJ Pharmaceutical 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-07-2023
Product Description About Product Description
Full technical description of the product.
SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwich CT 06830, NDC 66424-562-08, UPC 366424562082

Batch or Lot Expiration Information

Lot# : 47070042, Exp. 09/18

Affected Packages Involved in this Recall

66424-562-08 Senna Syrup