Cetylev — Class I drug recall D-0105-2017
Terminated recall by Arbor Pharmaceuticals Inc., reported 2016-10-26, distributed in CA, FL, GA, LA, MO, MS, NC, OH…. Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to eff
| Recall number | D-0105-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arbor Pharmaceuticals Inc., Atlanta, GA, United States |
| Recall initiated | 2016-07-21 |
| Classified | 2016-10-14 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2017-01-23 |
| Distributed | CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA, WV |
| Quantity | 16,932 cartons |
| Reason classes | packaging |
| NDC | 24338-0700-10 |
| Lot numbers | 005C16, 006C16, 007C16 |
| Expiration dates | 2018-02 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0105-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.