Phenylephrine Injection Recalled Due to Lack of Sterility Assurance
Anderson Compounding Pharmacy is recalling Phenylephrine 1 mg/mL Injection vials nationwide because the product lacks sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric. The hazard involves a lack of sterility assurance in an injectable medication, posing a significant risk of infection.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling Phenylephrine 1 mg/mL Injection, 10 mL Vials. The recall is being conducted because the product lacks sterility assurance.
The affected product is distributed nationwide. The recall includes all lots of the medication.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- Phenylephrine 1 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 68 recalled by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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