methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
Reported: October 25, 2017 Initiated: September 25, 2017 #D-0012-2018
Product Description
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
Reason for Recall
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Details
- Recalling Firm
- RXQ Compounding LLC
- Units Affected
- 945 vials
- Distribution
- TX, LA, PA, MA, FL, and OH
- Location
- Athens, OH
Frequently Asked Questions
What product was recalled? ▼
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10. Recalled by RXQ Compounding LLC. Units affected: 945 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 25, 2017. Severity: Moderate. Recall number: D-0012-2018.
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