CLASS II Drug recall · Reported 28 Dec 2016 · FDA Enforcement Report
C-pav/Phentol/Atrop/PGE1, All strengths, All sizes recalled
Colonia Care Pharmacy is recalling C-pav/Phentol/Atrop/PGE1, All strengths, All sizes, distributed in New Jersey, New York. The recall was initiated on 28 Jul 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0209-2017
- FDA event ID
- 74286
- Recalling firm
- Colonia Care Pharmacy, Colonia, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jul 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
Timeline
| 28 Jul 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +147 days |
| 28 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Where it was distributed
NJ and NY
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Which lots are affected?
All lots with Use by Date of 5/22/2016 to 8/31/2016
Where was it sold?
NJ and NY
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 74286| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | C-pav/Phentol/PGE1, All strengths, All sizes recalled | Colonia Care Pharmacy | Sterility | NJ, NY |