Colonia Care Pharmacy Recalls C-Cromolyn Sodium Inhalation Solution
Colonia Care Pharmacy is recalling C-Cromolyn Sodium 20 mg/2 mL inhalation solution due to a lack of assurance of sterility.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a medical product, which poses a significant risk of infection or serious injury.
Plain-English summary
Colonia Care Pharmacy is recalling C-Cromolyn Sodium 20 mg/2 mL inhalation solution, 120 mL in 60 nebulizer vials, prescription only. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed.
The affected product is identified by Lot # 070219B with a beyond-use date of 08/06/19. The recall involves patient-specific prescriptions distributed in New Jersey.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacy for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Colonia Care Pharmacy
- Category
- Drug — Inhalation Solution
- Hazard
- Affected units
- 60
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 (2)
- Lot #: 070219B
- BUD 08/06/19
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.
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