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
Reported: October 9, 2019 Initiated: July 24, 2019 #D-0003-2020
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.
Details
- Recalling Firm
- Colonia Care Pharmacy
- Units Affected
- 2 droptainer bottles
- Distribution
- Patient Specific Prescriptions in NJ
- Location
- Colonia, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Colonia Care Pharmacy. Units affected: 2 droptainer bottles.
Why was this product recalled? ▼
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 9, 2019. Severity: Moderate. Recall number: D-0003-2020.
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