Amneal Pharmaceuticals : UPDATE Revised Listing of NDC and Lot Numbers to be recalled

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 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 [e-mail].

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.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm1

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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.

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.

Contact:

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