D-0018-2020 Class II Terminated
FDA drug recall D-0018-2020 was initiated by Colonia Care Pharmacy on July 24, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: product sterility cannot be guaranteed. The recall status is terminated (terminated April 5, 2023). Affected quantity: 191 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- October 9, 2019
- Initiation Date
- July 24, 2019
- Termination Date
- April 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 191 syringes
Product Description
C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Reason for Recall
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Distribution Pattern
Patient Specific Prescriptions in NJ
Code Information
Lot #: 020719A, BUD 08/06/19; 051619E, BUD 11/12/19