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

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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