Why it was recalled
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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot numbers: 005C16, 006C16, 007C16, Exp 02/2018
Where it was sold
CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0105-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 21, 2016
- FDA report date
- Oct 26, 2016
- Quantity
- 16,932 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Arbor Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0105-2017, exactly as published.
Show all FDA fields
- City
- Atlanta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 74857
- Address
- 6 Concourse Pkwy
- Address (line 2)
- Suite 1800
- Code information
- Lot numbers: 005C16, 006C16, 007C16, Exp 02/2018
- Postal code
- 30328-6117
- Report date
- Oct 26, 2016
- Product type
- Drugs
- Recall number
- D-0105-2017
- Classification
- Class I
- Recalling firm
- Arbor Pharmaceuticals Inc.
- Product quantity
- 16,932 cartons
- Termination date
- Jan 23, 2017
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.
- Recall initiation date
- Jul 21, 2016
- Initial firm notification
- Center classification date
- Oct 14, 2016