D-0029-2020 Class II Terminated

Recalled by Colonia Care Pharmacy — Colonia, NJ

FDA drug recall D-0029-2020 was initiated by Colonia Care Pharmacy on Jul 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 Apr 5, 2023). Affected quantity: 1 vial.

Recall Details

Product Type
Drugs
Report Date
Oct 9, 2019
Initiation Date
Jul 24, 2019
Termination Date
Apr 5, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 vial

Product Description

C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, 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 #: 072419B, BUD 09/07/19

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0029-2020
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-0029-2020. Report a data issue: hello@regdatalab.com.