Recalls / Class I
Class ID-0272-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Affected lot / code info
- Lot 37-928390, Exp Date, 03MAR2025; Lot 37-928796, Exp Date, 09MAR2025; Lot 37-928839, Exp Date, 10MAR2025
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6580 Snowdrift Rd Ste 100, Allentown, Pennsylvania 18106-9331
Distribution
- Quantity
- 1546 bags
- Distribution pattern
- Product was distributed nationwide within the United States
Timeline
- Recall initiated
- 2025-02-20
- FDA classified
- 2025-03-11
- Posted by FDA
- 2025-03-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0272-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.