Recalls / Class II
Class IID-0021-2020
Product
C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Affected lot / code info
- Lot #: 072419C, BUD 09/07/19; 071519D, BUD 08/29/19
Why it was recalled
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Recalling firm
- Firm
- Colonia Care Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Inman Ave Ste A, N/A, Colonia, New Jersey 07067-1114
Distribution
- Quantity
- 2 vials
- Distribution pattern
- Patient Specific Prescriptions in NJ
Timeline
- Recall initiated
- 2019-07-24
- FDA classified
- 2019-10-01
- Posted by FDA
- 2019-10-09
- Terminated
- 2023-04-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0021-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.