Recall record at a glance
| Official record | D-0838-2016 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | VistaPharm, Inc. |
| Report date | May 11, 2016 |
| Recall initiation date | Apr 18, 2016 |
| Quantity | 8,901 cases |
| Location | Largo, FL, United States |
Official product description
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Why the product was recalled
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Distribution information
Nationwide
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
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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