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
Reported: November 25, 2015 Initiated: September 12, 2015 #D-0260-2016
Product Description
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
Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Details
- Recalling Firm
- US Compounding Inc
- Units Affected
- 1,706 vials
- Distribution
- Nationwide
- Location
- Conway, AR
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by US Compounding Inc. Units affected: 1,706 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 25, 2015. Severity: Moderate. Recall number: D-0260-2016.
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