Phenylephrine HCl Injectable Solution Recalled for Incorrect Concentration Labeling
Advanced Pharma Inc. is recalling 225 syringes of Phenylephrine HCl injectable solution because the label incorrectly states the concentration as 10 mcg per mL instead of 100 mcg per mL.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a severity score of 5 (Critical) due to the reasonable probability of serious adverse health consequences or death.
Plain-English summary
Advanced Pharma Inc. is recalling 225 syringes of Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution. The product is a 10 mL syringe, prescription-only injectable solution with NDC 42852-802-61. The recall is due to a labeling error where the concentration is incorrectly listed as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
The affected product, Lot 11/01/18 8847 80261S with a beyond-use date of 03/31/19, was distributed to healthcare facilities in New Mexico, Texas, and Ohio. The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.
Healthcare facilities should stop using the affected product and contact Advanced Pharma Inc. for further instructions. Consumers should not use this product if they have it in their possession and should contact their healthcare provider or the recalling firm for guidance.
The recalled product
- 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, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 225
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 11/01/18 8847 80261S
- BUD: 03/31/19
Distribution
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