US Compounding Recalls Phenylephrine Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 11 vials of Phenylephrine due to deficient practices that may impact sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a sterile injectable medication where sterility assurance is compromised, posing a significant risk of infection or serious injury.
Plain-English summary
US Compounding Inc is recalling 11 vials of Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, NDC 62295-3289-05. The product is a prescription-only medication intended for subcutaneous, intramuscular, intravenous, or penile injection. The specific lot code is 20150904@11 with a beyond-use date of 10/6/2015.
The recall was initiated because of deficient practices that may have an impact on sterility assurance. The firm is recalling all sterile preparations that are within expiry due to these concerns. The distribution pattern for this recall is nationwide.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3289-05
- Manufacturer
- US Compounding Inc
- Affected units
- 11
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 (1)
- Lot Code: 20150904@11 BUD: 10/6/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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