Home / Recalls / Colonia Care Pharmacy / D-0003-2020

D-0003-2020 Class II Terminated

Recalled by Colonia Care Pharmacy — Colonia, NJ

Recall Details

Product Type
Drugs
Report Date
October 9, 2019
Initiation Date
July 24, 2019
Termination Date
April 5, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 droptainer bottles

Product Description

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 Pattern

Patient Specific Prescriptions in NJ

Code Information

Lot #: a) 070819A, BUD 08/22/19; b) 071619F, BUD 08/30/19

Other recalls by Colonia Care Pharmacy

  • D-0028-2020 Class II — C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmac (July 24, 2019)
  • D-0023-2020 Class II — C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Ph (July 24, 2019)
  • D-0026-2020 Class II — C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmac (July 24, 2019)
  • D-0005-2020 Class II — C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Phar (July 24, 2019)
  • D-0014-2020 Class II — C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care (July 24, 2019)
  • D-0011-2020 Class II — C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy (July 24, 2019)
  • D-0022-2020 Class II — C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pha (July 24, 2019)
  • D-0004-2020 Class II — C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pha (July 24, 2019)
  • D-0008-2020 Class II — C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx (July 24, 2019)
  • D-0010-2020 Class II — C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Coloni (July 24, 2019)