PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Servi
Summary
The FDA issued a Class I for PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only by Central Admixture Pharmacy Services, Inc.. Reason: Presence of Particulate Matter.
Details
Source
Drug Recall
External ID
D-0272-2025
Action Date
2025-03-19
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot 37-928390, Exp Date, 03MAR2025; Lot 37-928796, Exp Date, 09MAR2025; Lot 37-928839, Exp Date, 10MAR2025
Quantity Affected: 1546 bags
Reason for Recall
Presence of Particulate Matter
Distribution
Product was distributed nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-20
Company
Allentown, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 61 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Central Admixture Pharmacy Services, Inc. has 307 FDA actions in our database, including 307 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Central Admixture Pharmacy Services, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Central Admixture Pharmacy Services, Inc. have FDA actions?
Central Admixture Pharmacy Services, Inc. has 307 FDA actions in our database, including 307 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0272-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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