D-1087-2018 Class II Terminated
FDA drug recall D-1087-2018 was initiated by Ranier's Compounding Laboratory on July 25, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. The recall status is terminated (terminated September 1, 2022). Affected quantity: 2 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 22, 2018
- Initiation Date
- July 25, 2018
- Termination Date
- September 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 vials
Product Description
Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Distribution Pattern
Product was distributed within the state of Pennsylvania.
Code Information
All lots within expiry