Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Voluntary Nationwide Recall of Cetylev® (Acetylcysteine) Effervescent Tablets for Oral Solution Due to an Inadequate Seal of the Blister Pack

For Immediate Release

August 18, 2016

Contact

Consumers

Arbor Pharmaceuticals, LLC
1-866-516-4950

Announcement

Arbor  Pharmaceuticals, LLC (Arbor) today announced a voluntary recall  of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral  solution, 500 mg, due to an inadequate seal  of the  blister pack.   An inadequate seal could result in an increase of oxygen and moisture entering the  blister cavity which  can  start the  effervescent process. This results in enlarged and swelled tablets which  could also completely dissolve within  the  blister pack.

Three lots of the  500 mg strength (Lot Numbers 005C16,  006C16  and 007C16,  expiration date

02/2018) with NDC 24338-700-10 are  included in the  recall.  Healthcare facilities  should immediately discontinue use  from these lots of product and return all unused Cetylev to Arbor.  To date, Arbor  has  not  received any reports of adverse events related to this recall. Product was distributed nationwide to wholesalers and pharmacies.

The improper seal  of the  product can  lead  to excess moisture and partial dissolution of the tablets. This can  lead  to a potentially sub-therapeutic dose as well as potential microbial contamination. Because the  effectiveness of acetylcysteine to prevent or lessen hepatic injury after ingestion of acetaminophen is delayed with decreased therapy, sub-therapeutic dosing could lead  to increased risk of liver injury. With regards to the  potential microbial contamination due to moisture ingress into  the  tablets, the  risk of serious infection is increased in certain patient populations such as children, pregnant women, immunosuppressed patients, and patients on gastric acid suppression therapy such as proton pump inhibitors.

Cetylev (acetylcysteine) effervescent tablets for oral  solution are  indicated as an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from

repeated supratherapeutic ingestion.

Consumers with questions regarding this recall  should contact Arbor  Pharmaceuticals, LLC at

1-866-516-4950, Monday through Friday, during business hours of 9:00 am  to 5:00 pm, Eastern Standard Time (EST). Please mention this notification when calling.  Consumers can contact their physician or healthcare provider if they  have additional questions about this 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.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.

About  Arbor:

Arbor  Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the  cardiovascular, hospital, pediatric and neurology markets.

Source: Arbor  Pharmaceuticals, LLC

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Page Last Updated: 08/18/2016
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