PharmaCaribe PulmoSal 7% Sodium Chloride Inhalation Solution Recalled for Mislabeling
Pharmacaribe LLC is recalling PulmoSal 7% Sodium Chloride inhalation solution because vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+).
The agency’s classification
FDA (Devices): 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a labeling error. The rubric assigns a score of 2 (Moderate) to minor labeling errors and voluntary precautionary recalls where no specific harm is reported.
Plain-English summary
Pharmacaribe LLC is recalling 7,020 vials of PulmoSal 7% Sodium Chloride, Inhalation Solution. The product is a sterile, preservative-free, non-pyrogenic solution with a pH of 7.4, intended for use with a nebulizer to induce sputum production. The recall is due to a labeling error where the vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+).
The affected product is identified by Lot # CIY with an expiration date of August 2017. The UPC number on the box of 60 vials is 030915339988, and the UPC number on the shipping case of 12 boxes is 10030915339985. The product was distributed nationwide in the states of Florida, Louisiana, Texas, and Virginia.
Consumers and healthcare providers should check their inventory for this specific lot and expiration date. If the product is found, it should be returned to the supplier or disposed of according to local regulations. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where…
- Manufacturer
- Pharmacaribe llc
- Hazard
- Affected units
- 7,020
Distribution
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