US Compounding Recalls Morphine PF Vials Due to Sterility Concerns
US Compounding Inc is recalling 5,919 vials of Morphine PF 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 lack of sterility assurance in an injectable medication, which poses a risk of serious infection or adverse health consequences.
Plain-English summary
US Compounding Inc is voluntarily recalling 5,919 vials of Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and was distributed nationwide.
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. The affected lot codes are 20151008@2, 20151307@2, and 20153107@27.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2171-02
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injectable Medication
- Affected units
- 5,919
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 (3)
- Lot Code: 20151008@2 BUD: 2/6/2016
- 20151307@2 BUD: 1/9/2016
- 20153107@27 BUD: 1/27/2016
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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