Injectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
The FDA is recalling phenylephrine injection solution due to particulate matter contamination. Three lot numbers distributed nationwide are affected.
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 product carries an FDA Class I classification, which mandates a minimum severity score of 4. Particulate matter in parenteral pharmaceutical products presents a serious risk to patient safety.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling PHENYLephrine added to 0.9% sodium chloride injection (40 mg/250 mL, 160 mcg/mL). The product has been issued a Class I recall due to the presence of particulate matter.
The recall involves three lot numbers: Lot 37-928390 (expiration 03MAR2025), Lot 37-928796 (expiration 09MAR2025), and Lot 37-928839 (expiration 10MAR2025). A total of 1,546 bags were distributed nationwide within the United States.
Particulate matter in parenteral pharmaceutical products is a serious contamination concern. Healthcare facilities that have received affected lot numbers should contact the manufacturer at 855-275-2270 or their facility address (6580 Snowdrift Rd., Ste 100, Allentown, PA 18106) for guidance regarding this recall.
The recalled product
- Product
- PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 1,546
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 (7)
- Lot 37-928390
- Exp Date
- 03MAR2025
- Lot 37-928796
- 09MAR2025
- Lot 37-928839
- 10MAR2025
Distribution
Distributed nationwide across the United States.
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