Phenylephrine HCl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Brand
Advanced Pharma Inc.
Lot Codes / Batch Numbers
Lots: 10/24/18 3318 83061S Exp. 3/23/2019, 10/18/18 3354 83061S Exp. 3/17/2019, 10/23/2018 6050 83061S Exp. 3/22/2019, 10/23/18 8105 83061S Exp. 3/22/2019, 10/18/18 1961 83061S Exp. 3/17/2019, 10/18/18 2598 83061S Exp. 3/17/2019, 11/05/18 1184 83061S Exp. 4/4/2019, 10/22/18 0737 83061S Exp. 3/21/2019, 10/25/18 1198 83061S Exp. 3/24/2019, 11/06/18 4451 83061S Exp. 4/5/2019, 11/06/18 0108 83061S Exp. 4/5/2019, 10/22/18 1530 83061S Exp. 3/21/2019
Products Sold
Lots: 10/24/18 3318 83061S Exp. 3/23/2019; 10/18/18 3354 83061S Exp. 3/17/2019; 10/23/2018 6050 83061S Exp. 3/22/2019; 10/23/18 8105 83061S Exp. 3/22/2019; 10/18/18 1961 83061S Exp. 3/17/2019; 10/18/18 2598 83061S Exp. 3/17/2019; 11/05/18 1184 83061S Exp. 4/4/2019; 10/22/18 0737 83061S Exp. 3/21/2019; 10/25/18 1198 83061S Exp. 3/24/2019; 11/06/18 4451 83061S Exp. 4/5/2019; 11/06/18 0108 83061S Exp. 4/5/2019; 10/22/18 1530 83061S Exp. 3/21/2019
Advanced Pharma Inc. is recalling Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg pe due to Lack of Assurance of Sterility. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026