Calcium Chloride IV Solution Recalled Due to Sterility Assurance Concerns
Pine Pharmaceuticals recalls Calcium Chloride IV Solution for Intravenous Injection, 20 mg/mL (lot 70101), due to lack of assurance of sterility. Approximately 130 units were distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves lack of assurance of sterility in an intravenous medication, representing a risk-of-harm product. No illnesses or injuries have been reported in the source text, limiting the score to 3 per the rubric criteria.
Plain-English summary
Pine Pharmaceuticals, LLC is recalling Calcium Chloride Solution for Intravenous Injection, 20 mg/mL supplied in 500 mL bags (Rx only). The affected lot is number 70101 with an expiration date of 1/17/2024. Approximately 130 units were distributed nationwide within the United States.
The product is being recalled due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Patients and healthcare facilities that received this lot should not use the product and should contact Pine Pharmaceuticals, LLC or their healthcare provider for further information.
The recalled product
- Product
- Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Manufacturer
- Pine Pharmaceuticals, LLC
- Category
- Drug
- Hazard
- Affected units
- 130
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 #: 70101
- Exp. Date 1/17/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Pine Pharmaceuticals, LLC 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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