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American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs

Reason for Announcement:

Recall Reason Description

NDMA (Nitrosodimethylamine) impurity

Company Name:
American Health Packaging
Brand Name:

Brand Name(s)

Product Description:

Product Description

Ranitidine Liquid Unit Dose Cups


Company Announcement

American Health Packaging is voluntarily recalling eight lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodimethylamine (NDMA). This recall is being initiated in response to the recall by the manufacturer (Lannett Company, Inc.), which included affected lots that were repackaged by American Health Packaging.

NDMA is classified as a probable human carcinogen, a substance that can cause cancer, based on laboratory testing. NDMA is also a known environmental contaminant found in water and foods, including meats, dairy and vegetables. No reports of injury or adverse events to date.

Ranitidine is used as a short-term treatment for active duodenal ulcers, maintenance therapy for duodenal ulcer patients, treatment of pathological hypersecretory conditions, short-term treatment of active, benign gastric ulcers, maintenance therapy for gastric ulcers, treatment of GERD and treatment of endoscopically diagnosed erosive esophagitis.

Product was distributed Nationwide to Wholesalers for use in hospital settings.

Product DescriptionAHP Lot No.Expiration Date
AHP Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups
Case NDC#: 60687-260-23
(Individual Dose NDC: 60687-260-42)
18372310/31/2020
18427810/31/2020
18765205/31/2021
AHP Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups
Case NDC#: 60687-260-69
(Individual Dose NDC: 60687-260-42)
17787401/31/2020
17841302/29/2020
18344910/31/2020
18444512/31/2020
18656303/31/2021

American Health Packaging has notified its distributors by recall letter, sent November 1st, 2019, to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. American Health Packaging is arranging for return of all recalled products to lnmar Pharmaceuticals Services. Instructions for returning recalled products are given in the recall letter. Pharmacies that have received the affected lot should contact (877) 475-5864 to receive a return packet. Hours of operation are 9:00am – 5:00pm, EST Monday thru Friday.

Any general questions regarding the return of this product please contact Inmar Pharmaceuticals Services at 800-967-5952 (option 1). Hours of operation are 9:00am – 5:00pm, EST Monday thru Friday.

Consumers with questions regarding this recall can contact Inmar Pharmaceuticals Services by 800-967-5952 (option 1). Hours of operation are 9:00am – 5:00pm, EST Monday thru Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using 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
  • Regular Mail or Fax: Download form 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

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


Company Contact Information

Consumers:
Inmar Pharmaceuticals Services


Product Photos

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Author: FDA

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