The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0003-2020·Announced 2019-10-09

Colonia Care Pharmacy Recalls C-Acetylcysteine Ophthalmic Solution Due to Sterility Concerns

Colonia Care Pharmacy is recalling specific lots of C-Acetylcysteine Ophthalmic 10% Solution because the sterility of the product 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Colonia Care Pharmacy is recalling C-Acetylcysteine Ophthalmic 10% Solution, packaged in 5 mL and 10 mL droptainer bottles. The recall involves two specific lots: Lot 070819A with a beyond-use date of 08/22/19, and Lot 071619F with a beyond-use date of 08/30/19.

The reason for the recall is a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed. This is a prescription-only medication distributed to patient-specific prescriptions in New Jersey.

Patients who have received this medication should contact their healthcare provider or pharmacy for further instructions on how to proceed.

The recalled product

Product
C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Manufacturer
Colonia Care Pharmacy
Category
Drug — Ophthalmic Solution
Hazard
Affected units
2

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 (4)

  • Lot #: a) 070819A
  • BUD 08/22/19
  • b) 071619F
  • 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.

See all 32 products in this recall →

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