US Compounding Recalls Brompheniramine Maleate Vials Due to Sterility Concerns
US Compounding Inc is recalling 589 vials of Brompheniramine Maleate due to deficient practices that may impact sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 lack of sterility assurance in sterile preparations, which poses a significant risk of serious health consequences such as infection, meeting the criteria for a Severe rating.
Plain-English summary
US Compounding Inc is recalling 589 vials of Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only. The product was compounded by US Compounding Pharmacy in Conway, Arkansas, and distributed nationwide. The recall includes specific lot numbers 20151205@11 with a best-use date of 11/7/2015, and 20151806@11 with a best-use date of 12/15/2015.
The recall is being conducted 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. This is an FDA Class II recall.
Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for instructions on return or disposal. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3019-07
- Manufacturer
- US Compounding Inc
- Category
- Drug — Sterile Injectable
- Affected units
- 589
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 (2)
- Lot Numbers: 20151205@11 BUD: 11/7/2015
- 20151806@11 BUD: 12/15/2015
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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