FDA recall D-0003-2020

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

Reason for recall

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Distribution

Patient Specific Prescriptions in NJ

Key facts

Status

Terminated

Initiation date

2019-07-24

Report date

2019-10-09

Termination date

2023-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Colonia, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0003-2020