The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0208-2017·Announced 2016-12-28

Colonia Care Pharmacy Recalls Injectable Drug Products Due to Sterility Concerns

Colonia Care Pharmacy is recalling C-PAV/PHENTOL/PGE1 injectable drug products due to lack of assurance of sterility. The recall affects products distributed in New Jersey and New York.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in injectable drug products, which poses a significant risk of serious injury or death if administered, fitting the 'Severe' criteria for significant injury reports or high-risk defects.

Plain-English summary

Colonia Care Pharmacy, located in Colonia, New Jersey, is recalling C-PAV/PHENTOL/PGE1 injectable drug products. The recall includes all strengths and sizes of the prescription-only medication. The specific reason for the recall is a lack of assurance of sterility, specifically concerning injectable drug products made with sterilized filtered stock solutions.

The affected products are identified by use-by dates ranging from May 22, 2016, to August 31, 2016. These products were distributed in New Jersey and New York. The recall is classified as Class II by the U.S. Food and Drug Administration.

Consumers and healthcare providers should stop using the affected products and contact their pharmacist or healthcare provider for further instructions. No specific illness or injury counts are provided in the source text.

The recalled product

Product
C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Manufacturer
Colonia Care Pharmacy
Category
Drug — Injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots with Use by Date of 5/22/2016 to 8/31/2016

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Colonia Care Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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