Recall record at a glance
| Official record | D-0347-2019 |
|---|---|
| Category | Drug Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Advanced Pharma Inc. |
| Report date | Jan 2, 2019 |
| Recall initiation date | Nov 29, 2018 |
| Quantity | 225 syringes |
| Location | Houston, TX, United States |
Official product description
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
Why the product was recalled
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Distribution information
Heath care facilities in NM, TX, and OH
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Telephone.
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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.