US Compounding Recalls L-Cysteine PF Vials Due to Sterility Concerns
US Compounding Inc is recalling 1,706 vials of L-Cysteine PF 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the risk of sterility failure in IV products is significant.
Plain-English summary
US Compounding Inc is recalling 1,706 vials of L-Cysteine PF (50 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 62295-3239-01. The specific lot number is 20151906@10, with a beyond-use date of 9/17/2015.
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 this lack of assurance of sterility.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and discontinue use if found.
The recalled product
- Product
- L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
- Manufacturer
- US Compounding Inc
- Category
- Drug — IV Compounded Medication
- Affected units
- 1,706
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 Numbers: 20151906@10 BUD: 9/17/2015
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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