Phenylephrine HCl Injection Recall Due to Particulate Matter
Provepharm Inc. is recalling Phenylephrine HCl Injection vials (Lot 24020027) due to the presence of particulate matter. The affected medication was distributed nationwide.
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 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: This recall is classified as FDA Class I, which carries a minimum severity score of 4 per the rubric. No deaths or hospitalizations are reported in the source text.
Plain-English summary
Provepharm Inc. is recalling Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials due to the presence of particulate matter. Particulate contamination in injectable products can pose serious health risks.
The recall affects 24,640 vials distributed nationwide in the United States. The affected lot is Lot 24020027 with an expiration date of 12/31/2025. Healthcare providers and patients who have received this medication should consult with their healthcare provider about this recall.
The recalled product
- Product
- Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426
- Manufacturer
- Provepharm Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 24,640
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# 24020027
- Exp Date: 12/31/2025
Distribution
Distributed nationwide across the United States.
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