Calcium Chloride Injectable Solution Recalled Due to Sterility Assurance Concerns
TMC Acquisition LLC is recalling Calcium Chloride Preservative Free injectable solution in 5 mL and 30 mL vials due to lack of assurance of sterility. The recall affects 138 vials distributed nationwide.
What this means for you
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 is an FDA Class II recall without reported illnesses or injuries. The hazard—lack of sterility assurance in an injectable medication—presents a potential health risk, but no actual contamination or adverse events have been reported, meeting the rubric criterion for High severity.
Plain-English summary
TMC Acquisition LLC, doing business as Tailor Made Compounding, is recalling Calcium Chloride Preservative Free 100 mg/mL injectable solution in 5 mL and 30 mL vials. A total of 138 vials are affected by this recall.
The recall was initiated due to lack of assurance of sterility. This is an FDA Class II recall, indicating a potential health risk from use of the product. No illnesses or injuries have been reported.
The recalled product was distributed nationwide in the United States and Puerto Rico. Healthcare providers and patients who have this medication should verify the batch numbers and expiration dates against those listed in the recall and should not use the affected vials. Affected vials should be returned to the manufacturer. Patients should consult their healthcare provider regarding alternative treatment options.
The recalled product
- Product
- Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Injectable Solution
- Hazard
- sterility-issue
- contamination-risk
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 (12)
- Batch #: a) 12072101A2
- Exp 3/7/2022
- 01042216A1
- Exp 4/4/2022
- 02142220A1
- Exp 5/15/2022
- b)12032129A2
- Exp 3/3/2022
- 03032213A1
- Exp 6/1/2022
- 03102214B
- Exp 6/8/2022.
Distribution
Distributed nationwide across the United States.
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