Ascorbic Acid Injectable Vials Recalled Due to Sterility Assurance Failure
Tailor Made Compounding is recalling ascorbic acid injectable vials due to lack of sterility assurance. The affected vials were distributed nationwide and in Puerto Rico.
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 FDA Class II recall involves lack of sterility assurance in an injectable pharmaceutical product, representing a risk-of-harm situation. No illnesses or injuries have been reported in the source text, placing this at the High severity level per the rubric criteria.
Plain-English summary
Tailor Made Compounding is recalling ascorbic acid 500mg/mL injectable vials because the company cannot assure that the product meets sterility standards. Affected vials include both 25 mL and 50 mL formats across multiple batches, totaling 657 units distributed nationwide in the USA and Puerto Rico.
A non-sterile injectable product poses a risk of serious infection to patients who receive it. The affected batch numbers and expiration dates are listed in FDA recall notice D-1195-2022.
Patients and healthcare providers who have or dispense these vials should stop use immediately. Contact Tailor Made Compounding or your pharmacy to return the product or for information about affected batches.
The recalled product
- Product
- Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Injectable / Compounded
- Hazard
- sterility-failure
- infection-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 (20)
- Batch #: a) 02282223A1
- Exp 8/27/2022
- 10112101A2
- Exp 4/9/2022
- 11032108A1
- Exp 4/30/2022
- 11222101A2
- Exp 5/21/2022
- b) 01042234B
- Exp 7/3/2022
- 01242211A2
- Exp 7/23/2022
- 02282222A1
- 10182101A1
- Exp 4/16/2022
- 11162112A1
- Exp 5/15/2022
- 12062105A2
- Exp 6/4/2022
- 12142143A2
Distribution
Distributed nationwide across the United States.
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