Recall record at a glance
| Official record | D-0612-2018 |
|---|---|
| Category | Drug Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Akorn, Inc. |
| Report date | Apr 4, 2018 |
| Recall initiation date | Mar 29, 2018 |
| Quantity | 48,176 unit dose cups |
| Location | Lake Forest, IL, United States |
Official product description
24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97012.
Why the product was recalled
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Distribution information
Nationwide in the USA
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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