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Unrated Drug recall · FDA · Published July 28, 2016

Colonia Care Pharmacy recalls injectable drugs with sterility concerns

Colonia Care Pharmacy recalls certain injectable drugs due to sterility risks. Products with use by dates from May 22, 2016 to August 31, 2016 are affected.

🇺🇸 FDA recall #D-0209-2017DrugColonia Care Pharmacy ›
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Recalling firmColonia Care Pharmacy515 Inman Ave Ste A · Colonia, NJ 07067-1114
✎ GovInfoNow plain-language explainer

What happened, in plain English

Colonia Care Pharmacy is recalling injectable drugs that may not be sterile. This could lead to infections if used improperly. Affected products have use by dates from May 22, 2016 to August 31, 2016. Read more at govinfonow.com/recall/42514-colonia-care-pharmacy-recalls-injectable-drugs-with-sterility-concerns.

Source Summary by GovInfoNow · govinfonow.com/recall/42514-colonia-care-pharmacy-recalls-injectable-drugs-with-sterility-concerns · Updated October 9, 2026 · FDA enforcement record: FDA #D-0209-2017

Cite this page

“Colonia Care Pharmacy recalls injectable drugs with sterility concerns.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42514-colonia-care-pharmacy-recalls-injectable-drugs-with-sterility-concerns. Based on FDA recall #D-0209-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0209-2017%22&limit=1).

Why it’s dangerous

The drugs were made using sterilized filtered stock solutions, which may not have been properly sterilized. This could lead to infections if the drugs are injected into the body.

Who’s affected

People who have prescription drugs with use by dates between May 22, 2016 and August 31, 2016 are affected. Those using these drugs for medical purposes are at higher risk.

How to tell if you have this one

Check the use by date on the product label. Products with use by dates from May 22, 2016 to August 31, 2016 are affected. The product names are C-PAV, PHENTOL, ATROP, and PGE1.

  • Brand
    Colonia Care Pharmacy
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    NJ and NY
Recall numberProduct, codes & lotsQuantity
D-0208-2017C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067; All lots with Use by Date of 5/22/2016 to 8/31/2016ALL
D-0209-2017C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067; All lots with Use by Date of 5/22/2016 to 8/31/2016N/A
Based on the official FDA remedy

What to do — step by step

  1. Check Product Date

    Look for use by dates from May 22, 2016 to August 31, 2016 on the product label.

Where it went and when

Where it was distributed

Distributed in New Jersey and New York.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “NJ and NY” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: New Jersey, New York.

Recall timeline

FDA terminated this recall 7.4 years after the firm started it.

1. Firm started the recall: Jul 28, 201612. FDA classified it Class II: Dec 22, 201623. Published in FDA’s Enforcement Report: Dec 28, 201634. FDA terminated the recall: Dec 6, 2023420162023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0209-2017 (July 28, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0209-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA