Amneal Pharmaceuticals Inc.

11/08/2019 | Press release | Distributed by Public on 11/08/2019 15:37

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due[...]

Company Contact:
Ms. Candis Edwards

email: [email protected]

FOR IMMEDIATE RELEASE - Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below.

Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

Amneal Pharmaceuticals, LLC. has not received any reports of adverse events that have been confirmed to be directly related to this recall. Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP), manufactured by Amneal, are prescription oral products. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

The Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) subject to the recall can be identified by NDC numbers stated on the product label:

Product

Strength

Pack Size

NDC Number

Ranitidine Tablets, USP

150 mg

60 count

65162-253-06

Ranitidine Tablets, USP

150 mg

100 count

65162-253-10

Ranitidine Tablets, USP

150 mg

180 count

65162-253-18

Ranitidine Tablets, USP

150 mg

500 count

65162-253-50

Ranitidine Tablets, USP

150 mg

1000 count

65162-253-11

Ranitidine Tablets, USP

300 mg

30 count

65162-254-03

Ranitidine Tablets, USP

300 mg

100 count

65162-254-10

Ranitidine Tablets, USP

300 mg

250 count

65162-254-25

Ranitidine Tablets, USP

300 mg

1000 count

65162-254-11

Ranitidine Tablets, USP

150 mg

500 count

53746-253-05

Ranitidine Tablets, USP

150 mg

1000 count

53746-253-10

Ranitidine Syrup (Ranitidine Oral Solution, USP)

15 mg/mL; 16 fl. oz.

473 mL

65162-664-90

The affected Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) were distributed directly to Wholesalers, Distributors, Retailers and Repackagers.

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers who purchased the impacted product directly from Amneal can call Stericycle at 866-918-8768, Monday - Friday, 8:00 am - 5:00 pm, EST to arrange for product return.

Consumers who have Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) which are being recalled should stop using the product and can call Stericycle at 866-918-8768, Monday - Friday, 8:00 am - 5:00 pm, EST for further information.

Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am - 6:00 pm, EST, or e-mail at [email protected]

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

The following lot numbers of Ranitidine Tablets, USP, 150 mg & 300 mg and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL are included in this recall.

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

Product Photos

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Safe Harbor Statement

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Words such as 'may,' 'will,' 'could,' 'expect,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'estimate,' 'assume,' 'continue,' and similar words are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Amneal Pharmaceuticals, Inc. (the 'Company'). Such risks and uncertainties include, but are not limited to, risks related to the products and recall thereof described in this press release. A further list and descriptions of these risks, uncertainties and other factors can be found in the Company's most recently filed Annual Report on Form 10-K for the fiscal year ended December 31, 2018, as supplemented by any subsequently filed Quarterly Reports on Form 10-Q. Copies of these filings are available online at www.sec.gov, www.amneal.com or on request from the Company.