Colonia Care Pharmacy Recalls C-Atropine Sulfate Ophthalmic Solution
Colonia Care Pharmacy is recalling C-Atropine Sulfate Ophthalmic Solution 0.02% because the product's sterility cannot be guaranteed.
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 the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in ophthalmic products) are rated as Severe.
Plain-English summary
Colonia Care Pharmacy is recalling C-Atropine Sulfate Ophthalmic Solution 0.02% in 5 mL droptainer bottles. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed.
The affected product is prescription-only and was distributed via patient-specific prescriptions in New Jersey. The specific lot number is 071619D, with a beyond-use date of 08/30/19.
Patients who have received this product should contact their healthcare provider or pharmacy for further instructions on how to proceed.
The recalled product
- Product
- C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Manufacturer
- Colonia Care Pharmacy
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 1
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 (2)
- Lot #: 071619D
- BUD 08/30/19
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 32 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.
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