US Compounding Recalls Zinc Sulfate Vials Due to Sterility Concerns
US Compounding Inc is recalling 562 vials of Zinc Sulfate 1 mg/mL 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 for an intravenous product, which poses a significant risk of serious health consequences such as infection.
Plain-English summary
US Compounding Inc is recalling 562 vials of Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and carries NDC 62295-3226-07. The recall covers two specific lot codes: 20150804@1 with a best-use date of 10/5/2015, and 20150907@1 with a best-use date of 1/5/2016.
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. The distribution pattern for these products is nationwide.
Healthcare providers and patients should stop using the affected vials and contact US Compounding Inc for further instructions or replacement. The FDA has classified this recall as Class II.
The recalled product
- Product
- Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3226-07
- Manufacturer
- US Compounding Inc
- Category
- Drug — IV Compounded Medication
- Affected units
- 562
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 Code: 20150804@1 BUD: 10/5/2015
- 20150907@1 BUD: 1/5/2016
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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