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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
Related recalls
Same manufacturer · Advanced Pharma Inc.
See all →- HighAdvanced Pharma Recalls Sub-Potent Hydromorphone Injectable Solution
FDA (Drugs) · 2019-05-08
- SevereAdvanced Pharma Recalls Lidocaine Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- HighAdvanced Pharma Recalls Glycopyrrolate Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Heparin Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Phenylephrine HCl Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- SevereAdvanced Pharma Recalls Phenylephrine HCl Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Phenylephrine HCl Injectable Syringes for Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Phenylephrine Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Phenylephrine HCl Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- ModerateHeparin Injectable Solution Recalled for Incorrect Concentration Labeling
FDA (Drugs) · 2019-01-30