D-0194-2017 Class II Terminated
FDA drug recall D-0194-2017 was initiated by Cantrell Drug Company on November 18, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility - the firm is recalling select sterile drug products. The recall status is terminated (terminated April 29, 2020). Affected quantity: 2509 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- December 21, 2016
- Initiation Date
- November 18, 2016
- Termination Date
- April 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2509 syringes
Product Description
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-002-03
Reason for Recall
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Distribution Pattern
Nationwide
Code Information
Lot: 8742