PhotoAmneal Pharmaceuticals of Bridgewater, N.J., is recalling Ranitidine tablets and syrup.

The products are contaminated with N-Nitrosodimethylamine (NDMA), a probable human carcinogen, above levels established by the FDA.

The products are used for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

There are no reports of adverse events.

Products with the following lot numbers are being recalled:

 

Ranitidine Tablets, USP, 150 mg

Description

Lot#

Expiration Date

Ranitidine Tablets, USP 150mg

AR180483B

3/31/2020

Ranitidine Tablets, USP 150mg

AR180559A

3/31/2020

Ranitidine Tablets, USP 150mg

AR180560A

3/31/2020

Ranitidine Tablets, USP 150mg

AR180594A

3/31/2020

Ranitidine Tablets, USP 150mg

AR180595A

3/31/2020

Ranitidine Tablets, USP 150mg

AR180675A

4/30/2020

Ranitidine Tablets, USP 150mg

AR180829A

4/30/2020

Ranitidine Tablets, USP 150mg

AR180831A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180832A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180868A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180868B

5/31/2020

Ranitidine Tablets, USP 150mg

AR180869A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180870A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180871A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180872A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180995A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180996A

5/31/2020

Ranitidine Tablets, USP 150mg

AR180997A

6/30/2020

Ranitidine Tablets, USP 150mg

AR180998A

6/30/2020

Ranitidine Tablets, USP 150mg

AR181158A

7/31/2020

Ranitidine Tablets, USP 150mg

AR181159A

7/31/2020

Ranitidine Tablets, USP 150mg

AR181160A

7/31/2020

Ranitidine Tablets, USP 150mg

AR181161A

7/31/2020

Ranitidine Tablets, USP 150mg

AR181690A

10/31/2020

Ranitidine Tablets, USP 150mg

AR181691A

10/31/2020

Ranitidine Tablets, USP 150mg

AR181692A

10/31/2020

Ranitidine Tablets, USP 150mg

AR181693A

10/31/2020

Ranitidine Tablets, USP 150mg

AR181694A

10/31/2020

Ranitidine Tablets, USP 150mg

AR181709A

10/31/2020

Ranitidine Tablets, USP 150mg

AR181710A

11/30/2020

Ranitidine Tablets, USP 150mg

AR181711A

11/30/2020

Ranitidine Tablets, USP 150mg

AR181806A

11/30/2020

Ranitidine Tablets, USP 150mg

AR181807B

11/30/2020

Ranitidine Tablets, USP 150mg

AR181807C

11/30/2020

Ranitidine Tablets, USP 150mg

AR181808A

11/30/2020

Ranitidine Tablets, USP 150mg

AR190004A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190005A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190006A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190007A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190008A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190008B

12/31/2020

Ranitidine Tablets, USP 150mg

AR190085A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190086A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190087A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190088A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190089A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190090A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190121A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190122A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190123A

12/31/2020

Ranitidine Tablets, USP 150mg

AR190124A

1/31/2021

Ranitidine Tablets, USP 150mg

AR190125B

1/31/2021

Ranitidine Tablets, USP 150mg

AR190181A

1/31/2021

Ranitidine Tablets, USP 150mg

AR190182A

1/31/2021

Ranitidine Tablets, USP 150mg

AR190183A

1/31/2021

Ranitidine Tablets, USP 150mg

AR190184A

1/31/2021

Ranitidine Tablets, USP 150mg

AR190364A

2/28/2021

Ranitidine Tablets, USP 150mg

AR190365A

2/28/2021

Ranitidine Tablets, USP 150mg

AR190366A

2/28/2021

Ranitidine Tablets, USP 150mg

AR190366B

2/28/2021

Ranitidine Tablets, USP 150mg

AR190509A

3/31/2021

Ranitidine Tablets, USP 150mg

AR190510A

3/31/2021

Ranitidine Tablets, USP 150mg

AR190542B

3/31/2021

Ranitidine Tablets, USP 150mg

AR190609A

3/31/2021

Ranitidine Tablets, USP 150mg

AR190610A

3/31/2021

Ranitidine Tablets, USP 150mg

HD03119A

3/31/2021

Ranitidine Tablets, USP 150mg

HD03219A

3/31/2021

Ranitidine Tablets, USP 150mg

HE03119A

4/30/2021

Ranitidine Tablets, USP 150mg

HE03219A

4/30/2021

Ranitidine Tablets, USP, 300 mg

Description

Lot#

Expiration Date

Ranitidine Tablets, USP 300mg

AR180519A

3/31/2020

Ranitidine Tablets, USP 300mg

AR180613A

3/31/2020

Ranitidine Tablets, USP 300mg

AR180615A

3/31/2020

Ranitidine Tablets, USP 300mg

AR180638A

3/31/2020

Ranitidine Tablets, USP 300mg

AR180640A

4/30/2020

Ranitidine Tablets, USP 300mg

AR180641A

4/30/2020

Ranitidine Tablets, USP 300mg

AR181156A

7/31/2020

Ranitidine Tablets, USP 300mg

AR181157A

7/31/2020

Ranitidine Tablets, USP 300mg

AR181795A

11/30/2020

Ranitidine Tablets, USP 300mg

AR181920A

12/31/2020

Ranitidine Tablets, USP 300mg

AR181921A

12/31/2020

Ranitidine Tablets, USP 300mg

AR181921B

12/31/2020

Ranitidine Tablets, USP 300mg

AR190414B

2/28/2021

Ranitidine Tablets, USP 300mg

AR190415A

2/28/2021

Ranitidine Tablets, USP 300mg

AR190416A

2/28/2021

Ranitidine Tablets, USP 300mg

AR190417A

2/28/2021

Ranitidine Tablets, USP 300mg

AR190418A

2/28/2021

Ranitidine Tablets, USP 300mg

AR190418B

2/28/2021

Ranitidine Tablets, USP 300mg

AR190543A

3/31/2021

Ranitidine Tablets, USP 300mg

AR190544A

3/31/2021

Ranitidine Tablets, USP 300mg

AR190545A

3/31/2021

Ranitidine Tablets, USP 300mg

AR190705A

4/30/2021

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL

Description

Lot#

Expiration Date

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL

06648001A

11/2019

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL

06648003A

04/2020

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL

06649001A

01/2021

The Ranitidine tablets and syrup being recalled can be identified by the following NDC numbers, which are on the product label:

Product

Strength

Pack Size

NDC Number

Ranitidine Tablets, USP150 mg60 count65162-253-06
Ranitidine Tablets, USP150 mg100 count65162-253-10
Ranitidine Tablets, USP150 mg180 count65162-253-18
Ranitidine Tablets, USP150 mg500 count65162-253-50
Ranitidine Tablets, USP150 mg1000 count65162-253-11
Ranitidine Tablets, USP300 mg30 count65162-254-03
Ranitidine Tablets, USP300 mg100 count65162-254-10
Ranitidine Tablets, USP300 mg250 count65162-254-25
Ranitidine Tablets, USP300 mg1000 count65162-254-11
Ranitidine Tablets, USP150 mg500 count53746-253-05
Ranitidine Tablets, USP150 mg1000 count53746-253-10
Ranitidine Syrup (Ranitidine Oral Solution, USP)15 mg/mL; 16 fl. oz.473 mL65162-664-90

What to do

Patients who have experienced any problems that may be related to the use of this recalled product. should contact their physician or healthcare provider

Consumers who have the recalled products should stop using them and can call Stericycle at (866) 918-8768, Monday – Friday, 8:00 am – 5:00 pm (EST) for further information.

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