Class II · Moderate risk
Cromolyn Sodium Oral Solution
CGMP deviation: product released prior to supplier approval.
C-Cromolyn Sod 20 Mg/2 Ml Inhalation Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Drug: Cromolyn
- Recalling firm
- Colonia Care Pharmacy
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0008-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Cromolyn recalls
See all
Class II · Moderate risk
Cromolyn Sodium Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Cromolyn Sodium Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
NasalCrom (cromolyn sodium)
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Class II · Moderate risk
Cromolyn sodium 1% inhalant solution packaged in a 3 mL or 7 mL vial
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Other recalls by Colonia Care Pharmacy
All 2019 recalls
Class II · Moderate risk
C-Verapamil 2.5mg/Ml Inj Soln
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Urea 40% Bladder Instill
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Tacrolimus 0.03% Ophthal Suspension
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Phenol/Cottonseed Oil Inj 5%
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
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