Phenylephrine Injectable Syringes Recalled for Sterility Assurance
Central Admixture Pharmacy Services Inc is recalling phenylephrine injectable syringes nationwide due to lack of assurance of sterility. The recall affects 19,510 units distributed across multiple lot numbers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II pharmaceutical recall for manufacturing control failure affecting product sterility assurance. No illnesses, hospitalizations, or injuries have been reported; the hazard is based on quality assurance concerns rather than confirmed contamination, placing this at score 3 per the rubric.
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling phenylephrine in 0.9% sodium chloride, supplied as 1,000 mcg/10 mL (100 mcg/mL) in 10 mL syringes. The recall affects 19,510 units distributed nationwide in the United States.
The recall was issued due to lack of assurance of sterility. The affected product cannot be guaranteed to meet sterility standards required for pharmaceutical use.
Customers who have received affected lot numbers should discontinue use immediately and contact the manufacturer or their distributor for instructions on product return or destruction.
The recalled product
- Product
- PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable
- Hazard
- sterility-failure
- contamination-risk
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 (20)
- Lot: 17-275152
- 17-275154
- 17-275155
- 17-275156
- 17-275163
- Exp. 10/1/2023
- 17-275234
- 17-275236
- 17-275251
- 17-275268
- 17-275270
- 17-275277
- Exp. 10/2/2023
- 17-275283
- 17-275294
- 17-275313
- Exp. 10/3/2023
- 17-275469
- 17-275471
- 17-275473
Distribution
Distributed nationwide across the United States.
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