D-0012-2018 Class II Terminated
FDA drug recall D-0012-2018 was initiated by RXQ Compounding LLC on September 25, 2017 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product. The recall status is terminated (terminated December 6, 2017). Affected quantity: 945 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- October 25, 2017
- Initiation Date
- September 25, 2017
- Termination Date
- December 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 945 vials
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.
Distribution Pattern
TX, LA, PA, MA, FL, and OH
Code Information
Lot: 04252017@1, exp 5/9/2018