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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging."
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.
- Manufacturer
- Arbor Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- 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
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