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.
Reported: January 2, 2019 Initiated: November 29, 2018 #D-0347-2019
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.
Reason for Recall
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".
Details
- Recalling Firm
- Advanced Pharma Inc.
- Units Affected
- 225 syringes
- Distribution
- Heath care facilities in NM, TX, and OH
- Location
- Houston, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Advanced Pharma Inc.. Units affected: 225 syringes.
Why was this product 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".
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 2, 2019. Severity: Critical. Recall number: D-0347-2019.
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