Phenylephrine HCl recall: Labeling Error
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…
Why was Phenylephrine HCl 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".
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 11/01/18 8847 80261S, BUD: 03/31/19
- Product
- 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…
- Recalling firm
- Advanced Pharma Inc.
- Quantity
- 225 syringes
- Distribution
- Heath care facilities in NM, TX, and OH
- Recall date
- January 2, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)