Reported Jan 2, 2019 · Terminated
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as…
Advanced Pharma Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Pharma Inc. · 9265 Kirby Dr · Houston, TX · 77054-2520
Is this the product you have?
- 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
- NDC42852-802-61
- Lot codes and dates
- Lot11/01/18 8847 80261S
- BUD03/31/19
- Amount recalled
- 225 syringes
Where it was sold
Why it was recalled
Stop using this product now
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".
Using this product could cause serious injury, illness or death — stop using it now.
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