Ephedrine Injectable Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 1,590 syringes of ePHEDrine due to lack of assurance of sterility. The product was distributed nationwide.
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 injectable medication recall with lack of sterility assurance. Inability to assure sterility in injectable products represents significant risk of potential contamination. This meets the rubric criterion of risk-of-harm products where injury has not yet been reported, and is capped at High per the rule that theoretical hazards without reported illness score at most 3.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL (10 mg/mL), 5 mL Syringe. Approximately 1,590 syringes are affected across lot numbers 17-275252, 17-275276 (expiring 10/2/2023), and 17-275525 (expiring 10/5/2023). The product was distributed nationwide in the United States.
The recall is due to lack of assurance that the product meets sterility standards. For injectable medications, the inability to assure sterility is a critical concern, as injectables must be free from microbial contamination to be safe for use.
Healthcare providers and pharmacies should immediately stop using these syringes and quarantine any remaining stock from the affected lots. Contact Central Admixture Pharmacy Services Inc. or the FDA for instructions on product return or disposal.
The recalled product
- Product
- ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable medication
- Hazard
- lack-of-sterility
- 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 (5)
- Lot: 17-275252
- 17-275276
- Exp. 10/2/2023
- 17-275525
- Exp. 10/5/2023
Distribution
Distributed nationwide across the United States.
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