Multi-event May 2019 FDA Recall Drug by Torrent Pharma Inc

This Multi-event Class II drug recall was voluntarily initiated by Torrent Pharma Inc on May 21, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States. and the recall is currently terminated.

Reported Recall Events

D-1373-2019 TERMINATED D-1362-2019 TERMINATED D-1364-2019 TERMINATED D-1348-2019 TERMINATED D-1367-2019 TERMINATED D-1369-2019 TERMINATED D-1368-2019 TERMINATED D-1345-2019 TERMINATED D-1385-2019 TERMINATED D-1360-2019 TERMINATED D-1378-2019 TERMINATED D-1361-2019 TERMINATED D-1370-2019 TERMINATED D-1379-2019 TERMINATED D-1356-2019 TERMINATED D-1377-2019 TERMINATED D-1359-2019 TERMINATED D-1372-2019 TERMINATED D-1375-2019 TERMINATED D-1383-2019 TERMINATED D-1382-2019 TERMINATED D-1384-2019 TERMINATED D-1380-2019 TERMINATED D-1374-2019 TERMINATED D-1366-2019 TERMINATED D-1355-2019 TERMINATED D-1346-2019 TERMINATED D-1376-2019 TERMINATED D-1350-2019 TERMINATED D-1363-2019 TERMINATED D-1354-2019 TERMINATED D-1352-2019 TERMINATED D-1353-2019 TERMINATED D-1371-2019 TERMINATED D-1381-2019 TERMINATED D-1351-2019 TERMINATED D-1347-2019 TERMINATED D-1349-2019 TERMINATED D-1358-2019 TERMINATED D-1365-2019 TERMINATED D-1357-2019 TERMINATED

Recall Number: D-1373-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
153.540 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, Manufactured By Bio-Pharm, Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.

Batch or Lot Expiration Information

Lot# s: 18E016; 18E029, Exp. 05/2020; 18F004; 18F005; 18F039, Exp. 06/2020; 18G010; 18G017, Exp. 07/2020; 18H019, Exp. 08/2020; 18M008, Exp. 12/2020; 19A005, Exp. 01/2021; 19B010, Exp. 02/2021.

Recall Number: D-1362-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
14,016 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663.

Batch or Lot Expiration Information

Lot# s: 18J005; 18J016; 18J025, Exp. 09/2020.

Recall Number: D-1364-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
6,000 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongestant, Cough Suppressant, 100 mg/30 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-301-16, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Inc., Allendale, NJ 07401.

Batch or Lot Expiration Information

Lot# s: 17E031, Exp. 05/2019; 18F030, Exp. 06/2020.

Recall Number: D-1348-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
2,646,228 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen 160 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC 0904-1985-20, b) One Pint (473 mL) bottle, NDC: 0904-1985-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Batch or Lot Expiration Information

Lot# s: a) 17E003; 17E038, Exp. 05/2019; 17F002; 17F005; 17F007; 17F025, Exp. 06/2019; 17G014, Exp. 07/2019; 17H015, Exp. 08/2019; 17J004; 17J006; 17J016, Exp. 09/2019; 17K008; 17K013; 17K021; 17K027, Exp. 10/2019; 17L021, Exp. 11/2019; 17M032, Exp. 12/2019; 18A023; 18A039, Exp. 01/2020; 18B007; 18B030; 18B037, Exp. 02/2020; 18C017; 18C026, Exp. 03/2020; 18D003; 18D034, Exp. 04/2020; 18E027; 18E033, Exp. 05/2020; 18F024; 18F033, Exp. 06/2020; 18G001; 18G023, Exp. 07/2020; 18J008; 18J009; 18J017; 18J027, Exp. 09/2020; 18K013; 18K014; 18K028, Exp. 10/2020. b) 17E006; 17E008, Exp. 05/2019; 17G001; 17G008;17G025, Exp. 07/2019; 17J022, Exp. 09/2019; 17K001; 17K007; 17K007A, Exp. 10/2019; 17L014, 17L034, Exp. 11/2019; 18A007; 18A007A, Exp. 01/2020; 18A025; 18A036, Exp. 01/2020; 18B018; 18B033; 18B034, Exp. 02/2020; 18D032; 18D035, Exp. 04/2020; 18E006; 18E035; 18E036, Exp. 05/2020; 18F033; 18F034, Exp. 06/2020; 18G007; 18G019, Exp. 07/2020; 18H008; 18H009; 18H025, Exp. 08/2020; 19A002, Exp. 01/2021.

Recall Number: D-1367-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
66,060 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg, Dextromethorphan HBr, USP 10 mg, Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10mL)), 4 Fl. oz. bottle, NDC: 0536-2310-97, Distributed by Rugby Laboratories, Livonia MI 48152.

Batch or Lot Expiration Information

Lot# s: 17E009, Exp. 05/2019; 17L004; 17L004A, 17L020, Exp. 11/2019; 17M029, Exp. 12/2019; 18C010; 18C025, Exp. 03/2020; 18J020, Exp. 09/2020.

Recall Number: D-1369-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
176,580 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0970-97, b) One Pint (473 mL) bottle, 0536-0970-85, Distributed by Rugby Laboratories, Livonia, MI 48152.

Batch or Lot Expiration Information

Lot# s: 17E034, Exp. 05/2019; 17L023, Exp. 11/2019; 17M027; 17M027A, Exp. 12/2019; 18A024, Exp. 01/2020; 18B029, Exp. 02/2020; 18C018; 18C021, Exp. 03/2020; 18E008, Exp. 05/2020.

Recall Number: D-1368-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
249,744 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle, NDC: 0536-0825-85, Distributed by Rugby Laboratories, Livonia, MI 48152.

Batch or Lot Expiration Information

Lot# s: 17F022, Exp. 06/2019; 17G027, Exp. 07/2019; 17H021; 17H021A, Exp. 08/2019; 17J008, Exp. 09/2019; 17L001, Exp. 11/2019; 17M015, Exp. 12/2019; 18A018, Exp. 01/2020; 18B003; 18B008, Exp. 02/2020; 18C012, Exp. 03/2020; 18D005, Exp. 04/2020; 18F008; 18F043, Exp. 06/2020; 18G025; 18H004, Exp. 07/2020; 18H007; 18H016, Exp. 08/2020.

Recall Number: D-1345-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
48,955 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.

Batch or Lot Expiration Information

Lot# s: 18F020, Exp. 06/2020; 18H013, Exp. 08/2020; 18J015, Exp. 09/2020; 18K015, 18K034, Exp. 10/2020; 19A014, Exp. 01/2021

Recall Number: D-1385-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Bisacodyl Suppositories, Brite Stock, Reese.

Batch or Lot Expiration Information

Lot# s: 17J003, Exp. 09/2019; 18A026, Exp. 01/2020; 18E031, Exp. 05/2020.

Recall Number: D-1360-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
24,384 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076.

Batch or Lot Expiration Information

Lot# s: 17F021, Exp. 06/2019; 17G013, Exp. 07/2019; 17K010, Exp. 10/2019; 18E015, Exp. 05/2020; 18F029; 18F031; 18F042, Exp. 06/2020; 18G024, Exp. 07/2020.

Recall Number: D-1378-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
82,872 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA.

Batch or Lot Expiration Information

Lot# s: 17L008, Exp. 05/2019; 17M019; 17M037, Exp. 06/2019; 18B012; 18K023, Exp. 04/2020.

Recall Number: D-1361-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
361,260 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD

Batch or Lot Expiration Information

Lot# s: 17E015; 17E024; 17E044, Exp. 05/2019; 17F018, Exp. 06/2019; 17G012, Exp. 07/2019; 17K024, Exp. 10/2019; 17M004, Exp. 12/2019; 18B017, Exp. 02/2020; 18H023, Exp. 08/2020.

Recall Number: D-1370-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
438,624 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) bottle., NDC: 0536-0770-85, Distributed by Rugby Laboratories, Livonia, MI 48152.

Batch or Lot Expiration Information

Lot# s: a) 17H025, Exp. 08/2019; 17M022, Exp. 12/2019; 18E011, Exp. 05/2020; 18G018, Exp. 07/2020; 18J014, Exp. 09/2020. b) 17E010; 17E030, Exp. 05/2019; 17F013, Exp. 06/2019; 17F010, Exp. 07/2019; 17J014, Exp. 09/2019; 17L005, Exp. 11/2019; 17M017, Exp. 12/2019; 18A022, Exp. 01/2020; 18B021, Exp. 02/2020 18D017, Exp. 04/2020; 18E011, Exp. 05/2020; 18F041, Exp. 06/2020; 18G021; 18H022; 18H028; 18H030, Exp. 08/2020.

Recall Number: D-1379-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
177,408 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Batch or Lot Expiration Information

Lot# s: 17L008, Exp. 05/2019; 17M011; 17M037, Exp. 06/2019; 18A015, Exp. 07/2019; 18B012; 18B023, Exp. 08/2019; 18K023; 18K029, Exp. 04/2020; 18L014, Exp. 05/2020; 19A001, Exp. 06/2020.

Recall Number: D-1356-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
17,748 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant, nasal decongestant, Chlorpheniramine Maleate, USP 2 mg; Dextromethorphan HBr, USP 10 mg; Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10 mL)), 4 Fl. oz. (118 mL) bottle, NDC:0904-5050-20, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Batch or Lot Expiration Information

Lot# s: 17L020, Exp. 11/2019; 18C025, Exp. 03/2020; 18J020, Exp. 09/2020.

Recall Number: D-1377-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
120,204 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC: 0536-1355-12, b) 100 Suppositories per carton, NDC: 0536-1355-01, Distributed Rugby Laboratories, Livonia, MI 48152.

Batch or Lot Expiration Information

Lot# s: a) 17K009, Exp. 10/2019; 17M028, Exp. 12/2019; 18F003, Exp. 06/2020; 18J022, Exp. 09/2020; 18L012, Exp. 11/2020; 19A008, Exp. 01/2021. b) 17G004; 17G028, Exp. 07/2019; 18A034, Exp. 01/2020; 18C016, Exp. 03/2020; 18E005, Exp. 05/2020; 18F038, Exp. 06/2020; 18G015, Exp. 07/2020; 18H024, Exp. 08/2020; 18K024, Exp. 10/2020; 18L011, Exp. 11/2020; 19A009, Exp. 01/2021; 18D033, Exp. 04/2020; 18E025, Exp. 05/2020.

Recall Number: D-1359-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
53,520 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Skokie IL 60076.

Batch or Lot Expiration Information

Lot# s: 17E039, Exp. 05/2019; 17K016, Exp. 10/2019; 18E021, Exp. 05/2020; 18G008, Exp. 07/2020.

Recall Number: D-1372-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
96,060 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz., NDC: 13668-580-12, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.

Batch or Lot Expiration Information

Lot# s: a) 18K025; 18K027, Exp. 10/2020; 18L001; 18L006; 18L007, Exp. 11/2020; 18M013, Exp. 12/2020; 19A006, Exp. 01/2021. b) 18K027, Exp. 10/2020; 19A006, Exp. 01/2021.

Recall Number: D-1375-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
264 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured By Bio-Pharm Inc., Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.

Batch or Lot Expiration Information

Lot# : 18F026, Exp. 06/2020.

Recall Number: D-1383-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
11,112 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA.

Batch or Lot Expiration Information

Lot# s: 18B013, Exp. 02/2020; 18E024; 18E030, Exp. 05/2020.

Recall Number: D-1382-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
52,368 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816.

Batch or Lot Expiration Information

Lot# s: 17F012; 17F012A, Exp. 06/2019; 17G031, Exp. 07/2019; 17H004; 17H031, Exp. 08/2019; 18B004, Exp. 02/2020; 18C028, Exp. 03/2020

Recall Number: D-1384-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
7,728 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.

Batch or Lot Expiration Information

Lot# s: 18E034, Exp. 05/2020; 19A015, Exp. 01/2021.

Recall Number: D-1380-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
1,126,404 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724.

Batch or Lot Expiration Information

Lot# s: 17E021; 17E023; 17E040; 17E042, Exp. 05/2019; 17F017, Exp. 06/2019; 17G030; 17G033, Exp. 07/2019; 17H013, Exp. 08/2019; 17J007; 17J024, Exp. 09/2019; 17K003; 17K011, Exp. 10/2019; 17L016; 17L022, Exp. 11/2019; 17M001; 17M021; 17M030, Exp. 12/2019; 18A027; 18A037, Exp. 01/2020; 18B001, Exp. 02/2020; 18C005; 18C006; 18C007, Exp. 03/2020.

Recall Number: D-1374-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
5,681 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma

Batch or Lot Expiration Information

Lot# s: 17E001, Exp. 05/2019; 17F014, Exp. 06/2019; 17G005; 17G010, Exp. 07/2019; 17J019; 17J021, Exp. 09/2019; 17M008; 17M009, Exp. 12/2019.

Recall Number: D-1366-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
1,883,796 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored, a) 4 Fl. oz. bottle, NDC: 0536-0122-97, b) One Pint (473 mL) bottle, NDC: 0536-0122-85, Distributed by Rugby Laboratories, Lavonia, MI 48152 USA.

Batch or Lot Expiration Information

Lot# s: a) 17E022; 17E037, Exp. 05/2019; 17G006; 17G026, Exp. 07/2019; 17H019; 17H020, Exp. 08/2019; 17J020, Exp. 09/2019; 17K006; 17K012, Exp. 10/2019; 17L028; 17L033, Exp. 11/2019; 18A001; 18A006; 18A013; 18A038, Exp. 01/2020; 18B036, Exp. 02/2020; 18C024, Exp. 03/2020; 18E009; 18E019; 18E028, Exp. 05/2020; 18F010, Exp. 06/2020; 18H003, Exp. 08/2020; 18J010; 18J012; 18J013; 18J019, Exp. 09/2020; 18K003; 18K012, Exp. 10/2020; 19A016, Exp. 01/2021. b) 17E036, Exp. 05/2019; 17F008; 17F008A, Exp. 06/2019; 17H030, Exp. 08/2019; 17K017, Exp. 10/2019; 17L017, Exp. 11/2019; 17M031, Exp. 12/2019; 18A020; 18A040, Exp. 01/2020; 18B036, Exp. 02/2020; 18C032, Exp. 03/2020; 18E004; 18E032, Exp. 05/2020; 18F001, Exp. 06/2020; 18H006, Exp. 08/2020; 18K032, Exp. 10/2020; 18L003, Exp. 11/2020; 19A007, Exp. 01/2021.

Recall Number: D-1355-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
262,008 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP 200 mg in each 2 teaspoonfuls (10mL)), 4 Fl. oz. (118 mL) bottle, NDC: 0904-6306-20, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Batch or Lot Expiration Information

Lot# s: 17E016; 17E017, Exp. 05/2019; 17F023; 17F023A, Exp. 06/2019; 17L018; 17L029; 17L030; 17L031, Exp. 11/2019; 17M035, Exp. 12/2019; 18B002; 18B014; 18B035, Exp. 02/2020; 18C002; 18C019, Exp. 03/2020; 18D013, Exp. 04/2020.

Recall Number: D-1346-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
58,272 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL) bottle, NDC: 59741-101-06, Manufactured by Bio-Pharm, Inc., Levittown PA 19057, Assured.

Batch or Lot Expiration Information

Lot# : 17E035, Exp. 05/2019

Recall Number: D-1376-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
140,436 suppositories

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton, NDC: 59741-301-12, b) 24 Adult Suppositories per carton, NDC: 59741-301-24, Manufactured by Bio-Pharm Inc., Levittown PA 19057.

Batch or Lot Expiration Information

Lot# s: a) 17L010, Exp. 11/2019; 18D018, Exp. 04/2020; 18F022; 18F022A, Exp. 06/2020. b) 17L019; 17L026, Exp. 11/2019; 18B005, Exp. 02/2020; 18D006, 18D012; 18D022, Exp. 04/2020; 18K006, Exp. 10/2020.

Recall Number: D-1350-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
131,328 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6479-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.

Batch or Lot Expiration Information

Lot# s: 17M003, Exp. 12/2019; 18A009; 18A010, Exp. 01/2020; 18B024, Exp. 02/2020; 18F021; Exp. 06/2020; 18G009; 18G020, Exp. 07/2020; 18K005; 18K011; Exp. 10/2020.

Recall Number: D-1363-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
233,388 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663

Batch or Lot Expiration Information

Lot# s: 17H002; 17H005; 17H006; 17H007; 17H026; 17H027, Exp. 08/2019; 17J010; 17J013, Exp. 09/2019; 17K014; 17K015, Exp. 10/2019; 17L015, Exp. 11/2019; 17M026, Exp. 12/2019; 18A028; 18A031, Exp. 01/2020; 18B026, Exp. 02/2020; 18E003, Exp. 05/2020.

Recall Number: D-1354-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
3,788,502 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL) bottle, NDC:0904-5711-35, b) 1 FL. oz. (30 mL) bottle, NDC: 0904-5711-30, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Batch or Lot Expiration Information

Lot# s: a) 17E032, Exp. 05/2019; 17F011; 17F020, Exp. 06/2019; 17G003; 17G011, Exp. 07/2019; 17H016, Exp. 08/2019; 17J005; 17J017; 17J026, Exp. 09/2019; 17K029, Exp. 10/2019; 17L027, Exp. 11/2019; 18A003; 18A004; 18A033, Exp. 01/2020; 18B011, Exp. 02/2020; 18C029, Exp. 03/2020; 18D019; 18D025, Exp. 04/2020; 18F014, Exp. 06/2020; 18H029, Exp. 08/2020; 18J007; 18J018, Exp. 09/2020; 18K007; 18K026, Exp. 10/2020; 19A012, Exp. 01/2021. b) 17E011, Exp. 05/2019; 17E012, Exp. 06/2019; 17G019; 17G023, Exp. 07/2019; 17H011, Exp. 08/2019; 17J029, Exp. 09/2019; 17K005, Exp. 10/2019; 17M005; 17M018, Exp. 12/2019; 18C001; 18C004, Exp. 03/2020; 18F032; 18F019, Exp. 06/2020.

Recall Number: D-1352-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
655,104 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful contains diphenhydramine hydrochloride, USP 12.5 mg, a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-1228-00, b) One Pint (473 mL) bottle, NDC: 0904-5174-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Batch or Lot Expiration Information

Lot# s: a)17E018; 17E020, 17E026, Exp. 05/2019; 17H008; 17H018; 17H028, Exp. 08/2019; 17J002; 17J025; 17J028, Exp. 09/2019; 17L035, Exp. 11/2019; 17M024, Exp. 12/2019; 18A017, Exp. 01/2020; 18B016, Exp. 02/2020; 18C011, Exp. 03/2020; 18D014; 18D021; 18D026, Exp. 04/2020; 18E014, Exp. 05/2020; 18F036, Exp. 06/2020; 18F035; 18G018, Exp. 07/2020; 18H005; 18H015, Exp. 08/2020; 19A011; 19A013, Exp. 01/2121. b) 17E013; 17E025; 17E028; 17E041, Exp. 05/2019; 17F009; 17F016, Exp. 06/2019; 17G007; 17G021; 17G032, Exp. 07/2019; 17H023, Exp. 08/2019; 17J001; 17J012; 17J023; 17J027, Exp. 09/2019; 17K004; 17K022; 17K028; 17K028A, Exp. 10/2019; 17L032; Exp. 11/2019; 17M036, Exp. 12/2019; 18A011; 18A019; 18A030; 18A032; 18A041, Exp. 01/2020; 18B010; 18B038, Exp. 02/2020; 18C008; 18C022; 18C030, Exp. 03/2020; 18D004; 18D008; 18D010; 18D011, Exp. 04/2020; 18F028; 18H010, Exp. 06/2020; 18G004; 18G012, Exp. 07/2020; 18H002; 18H011; 18H027; 18H032; 18H033, Exp. 08/2020; 18K008; 18K009, Exp. 10/2020.

Recall Number: D-1353-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
1,436,904 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant, One Pint (473 mL) bottle, NDC: 0536-1850-85, Distributed by Rugby Laboratories, Livonia MI 48152.

Batch or Lot Expiration Information

Lot# s: 17H012, Exp. 08/2019; 17L011, Exp. 11/2019; 17M020, Exp. 12/2019; 18D007, Exp. 04/2020; 18J001, Exp. 09/2020.

Recall Number: D-1371-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
62,748 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118 mL) bottle, NDC:0536-1850-97, Distributed by Rugby Laboratories, Livonia MI 48152.

Batch or Lot Expiration Information

Lot# s: 17G002, Exp. 07/2019; 17H024, Exp. 08/2019; 17M023, Exp. 12/2019; 18F012, Exp. 06/2020.

Recall Number: D-1381-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
730,476 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..

Batch or Lot Expiration Information

Lot# s: a)
Lot# : 18D027, 18D028, 18D029; Exp. 04/2020. b) 18D029A, Exp. 04/2020; 18E001B; 18E010B, Exp. 05/2020; 18F016A; 18F017A; 18F037A, Exp. 06/2020; 18J021; 18J023; 18J023A; 18J024, Exp. 09/2020; 18K001; 18K002, Exp. 10/2020; 19A003; 19A022, Exp. 01/2021; 19B009, Exp. 02/2021.

Recall Number: D-1351-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
1,500,672 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0053-00, b) 8 oz. bottle, NDC: 0904-0053-09, c) 16 oz. bottle, NDC:0904-0053-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.

Batch or Lot Expiration Information

Lot# s: a) 17F001, Exp. 06/2019; 17G016, Exp. 07/2019; 17H017, Exp. 08/2019;17L002; 17L024, Exp. 11/2019; 17M010; 17M013, Exp. 12/2019; 18B006; 18B031, Exp. 02/2020; 18C033, Exp. 03/2020; 18D015; 18D016, Exp. 04/2020; 18E020, Exp. 05/2020; 18G013, Exp. 07/2020; 18L010, Exp. 11/2020; 19A010; 19A019, Exp. 01/2021 b) 17F015, Exp. 06/2019; 17L009, Exp. 11/2019; 17M012, Exp. 12/2019; 18B015, Exp. 02/2020; 18C034, Exp. 03/2020; 18E026, Exp. 05/2020; 18G011, Exp. 08/2020. c) 17E014, Exp. 05/2019; 17G009;17G020, Exp. 07/2019; 17K019, Exp. 10/2019; 17L012; 17L013, Exp. 11/2019; 17M016; 17M033, Exp. 12/2019; 18A002, Exp. 01/2020; 18B009; 18B019, Exp. 02/2020; 18C015; 18C035, Exp. 03/2020; 18D001; 18D002, Exp. 04/2020; 18E018, Exp. 05/2020; 18F027, Exp. 06/2020; 18H017; 18H018, Exp. 08/2020; 18K016; 18K035, Exp. 10/2020.

Recall Number: D-1347-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
118,080 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 4 FL. oz. (118 mL) bottle, NDC: 59741-119-06, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Assured.

Batch or Lot Expiration Information

Lot# s: 17E019; 17E045, Exp. 05/2019

Recall Number: D-1349-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
984,888 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-0061-00, b) One Pint ( 473 mL) bottle, NDC: 0904-0061-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Batch or Lot Expiration Information

Lot# s: a) 17F003, Exp. 06/2019; 17J011, Exp. 09/2019; 17K018; 17K020, Exp. 10/2019; 17M014; 17M034, Exp. 12/2019; 18A035; Exp. 01/2020; 18B022; 18B027, Exp. 02/2020; 18C036, Exp. 03/2020; 18D009; 18D024, Exp. 04/2020. b) 17G018, Exp. 07/2019; 17H001; 17H010; 17H014, Exp. 08/2019; 17J009, Exp. 09/2019; 17K023, Exp. 10/2019; 17L006; 17L025, Exp. 11/2019; 17M025; 17M034; Exp. 12/2019; 18A005; 18A012; 18A016, Exp. 01/2020; 18B020, Exp. 02/2020; 18C023; 18C031, Exp. 03/2020; 18E017, Exp. 05/2020; 18G005; 18G022, Exp. 07/2020; 18H021; 18H026, Exp. 08/2020; 18J003Exp. 09/2020.

Recall Number: D-1358-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
66,798 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin Pharma, Skokie, IL 60076.

Batch or Lot Expiration Information

Lot# s: 17L003, Exp. 05/2019; 18A021, Exp. 07/2019; 18C027, Exp. 09/2019; 18D020, Exp. 10/2019; 18E007, 18E022, Exp. 11/2019; 18F006; 18F007; 18F023; 18F023A; 18F040, Exp. 12/2019; 19A004, Exp. 07/2020.

Recall Number: D-1365-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
148,440 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle, NDC:16571-330-16, Manufactured by Bio-Pharm Inc., Levittown, PA 10957, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663.

Batch or Lot Expiration Information

Lot# s: 17E007, Exp. 05/2019; 17F026, Exp. 06/2019; 17G015, Exp. 07/2019; 17K002; 17K026, Exp. 10/2019; 17M002, Exp. 12/2019; 18C020, Exp. 03/2020; 18D023, Exp. 04/2020; 18F009, Exp. 06/2020; 18K030, Exp. 10/2020.

Recall Number: D-1357-2019

Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Initiated
05-21-2019
Reported
06-19-2019
Quantity
391,404 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82889
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.
Torrent Pharma 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.
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC: 0904-5058-12, b) 100 suppositories per carton, NDC: 0904-5058-60, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.

Batch or Lot Expiration Information

Lot# s: a) 17E004; 17E033, Exp. 05/2019; 17F019, Exp. 06/2019; 17G017, Exp. 07/2019; 17K009; 17K030; Exp. 10/2019, 17M006; 17M028, Exp. 12/2019; 18A029, Exp. 01/2020; 18C037, Exp. 03/2020; 18E002, Exp. 05/2020; 18F003; 18F013, Exp. 06/2020; 18G002; 18G016, Exp. 07/2020; 18H031, Exp. 08/2020; 18J004, 09/2020; 18L008; 18L012, Exp. 11/2020; 19A008, Exp. 01/2021. b) 17E005; 17E027, Exp. 05/2019; 17K025, Exp. 10/2019; 17M006, Exp. 12/2019; 18A014, Exp. 01/2020; 18B039, Exp. 02/2020; 18C037, Exp. 03/2020; 18D033, Exp. 04/2020; 18E025, Exp. 05/2020; 18F013; 18F018, Exp. 06/2020; 18G003, Exp. 07/2020; 18H012; 18H014, Exp. 08/2020; 18J026, Exp. 09/2020; 18L009, Exp. 11/2020; 18M014, Exp. 12/2020; 19A021, Exp. 01/2021; 19B001; 19B002, Exp. 02/2021.