US Compounding Recalls Phenylephrine PF Syringes Due to Sterility Concerns
US Compounding Inc is recalling 14,580 vials of Phenylephrine PF IV syringes nationwide 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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in IV products are categorized as Severe.
Plain-English summary
US Compounding Inc is recalling 14,580 vials of Phenylephrine PF (1 mg/10 mL) 10 mL Single Use Syringes for IV use. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry dates. The FDA has classified this recall as Class II.
Healthcare providers and patients should discontinue use of the affected syringes and contact their pharmacist or the recalling firm for further instructions. The specific lot codes and best-use dates are listed in the official recall notice.
The recalled product
- Product
- Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07
- Manufacturer
- US Compounding Inc
- Category
- Drug — IV Sterile Preparation
- Affected units
- 14,580
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 (12)
- Lot Code: 20150806@1 BUD: 12/5/2015
- 20150806@2 BUD: 12/5/2015
- 20151105@4 BUD: 11/7/2015
- 20151105@6 BUD: 11/7/2015
- 20151407@3 BUD: 1/10/2016
- 20151603@1 BUD: 9/12/2015
- 20151805@25 BUD: 11/14/2015
- 20151805@28 BUD: 11/14/2015
- 20152206@17 BUD: 12/19/2015
- 20152707@1 BUD: 1/23/2016
- 20153003@1 BUD: 9/26/2015
- 20152003@2 BUD: 9/26/2015
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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