Agency classClass IIOur severity:High FDA (Drugs)·D-1198-2022·Announced 2022-07-20

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.

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 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
Affected units: 138

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 52 recalled by TMC Acquisition LLC dba Tailor Made Compounding 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.

See all 52 products in this recall →

Same manufacturer · TMC Acquisition LLC dba Tailor Made Compounding

See all →

High
Dexpanthenol Preservative Free Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-07-20
High
Hydroxocobalamin Compounded Injections Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
High
Tailor Made Compounding Recalls Glycyrrhizic Acid Injectable for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
High
FDA Recalls Tailor Made Compounding GAC Injectable Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
High
Estradiol Cypionate Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20

Same hazard · sterility issue