The Recall Desk
ModerateFDA (Drugs)·D-0105-2017·Announced 2016-10-26

Arbor Pharmaceuticals Recalls Cetylev Tablets Due to Defective Blister Packaging

Arbor Pharmaceuticals is recalling Cetylev (acetylcysteine) effervescent tablets because incomplete seals on the blister packaging allow moisture to enter, causing the tablets to swell.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which mandates a minimum score of 4 per the rubric, despite the defect being a packaging issue without reported injuries.

Plain-English summary

Arbor Pharmaceuticals Inc. is recalling 16,932 cartons of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg. The affected product is distributed in California, Florida, Georgia, Louisiana, Missouri, Mississippi, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and West Virginia. The recall involves lot numbers 005C16, 006C16, and 007C16, which have an expiration date of 02/2018.

The recall is being conducted due to a defective container issue. Specifically, the blister packaging has incomplete seals that allow oxygen and moisture to enter. This exposure initiates the effervescence process, leading to the tablets swelling and enlarging. The source text does not report any illnesses or injuries associated with this defect.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or Arbor Pharmaceuticals for further instructions or a refund.

The recalled product

Product
Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count blister packs), Distributed by Arbor Pharmaceuticals, LLC Atlanta, GA 30328, NDC 24338-700-10.
Affected units
16,932

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot numbers: 005C16
  • 006C16
  • 007C16
  • Exp 02/2018

Distribution

Distributed in 14 states:

Same manufacturer · Arbor Pharmaceuticals Inc.

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