Colonia Care Pharmacy Recalls Injectable Drug Products Due to Sterility Concerns
Colonia Care Pharmacy is recalling C-PAV/PHENTOL/ATROP/PGE1 injectable 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, which corresponds to a Severe severity score (4) according to the rubric, particularly given the risk of infection associated with non-sterile injectable products.
Plain-English summary
Colonia Care Pharmacy is recalling all strengths and sizes of C-PAV/PHENTOL/ATROP/PGE1, a prescription-only injectable drug product. The recall is being conducted due to a lack of assurance of sterility, specifically concerning injectable drug products made with sterilized filtered stock solutions.
The affected products are all lots with a Use by Date between May 22, 2016, and August 31, 2016. These products were distributed in New Jersey and New York.
Consumers and healthcare providers should stop using these products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
- Manufacturer
- Colonia Care Pharmacy
- Category
- Drug — Injectable
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
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 →Related recalls
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