Methylene Blue Hypotonic Solution Vials Recalled for Sterility Assurance Failure
Methylene Blue Hypotonic Solution vials are being recalled nationwide and in Puerto Rico due to lack of assurance of sterility. Affected vials should not be used.
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: FDA Class II recall affecting an injectable pharmaceutical with no reported illnesses or injuries. The lack of sterility assurance for an injectable compounded product presents a risk of harm, meeting the criteria for High severity as a risk-of-harm product without documented adverse events.
Plain-English summary
TMC Acquisition LLC dba Tailor Made Compounding is recalling Methylene Blue Hypotonic Solution 10 mg/mL in both 2 mL and 10 mL vials due to lack of assurance of sterility. The recall affects 464 vials distributed nationwide in the USA and Puerto Rico.
The recalled vials include the following batch numbers and expiration dates: 2 mL vials (11032122A2 exp 4/30/2022, 01142226A1 exp 7/13/2022) and 10 mL vials (10272101A1 exp 4/25/2022, 11292137A1 exp 5/28/2022, 12142120A2 exp 6/12/2022, 01042235B exp 7/3/2022, 01142226A1 exp 7/13/2022, 03012240A1 exp 8/28/2022, 03042223A1 exp 8/31/2022).
Individuals and healthcare facilities in possession of these vials should not use them. The vials should be handled and discarded according to proper procedures for pharmaceutical waste.
The recalled product
- Product
- Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Injectable
- Hazard
- sterility-failure
- contamination
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 (16)
- Batch #: a)11032122A2
- Exp 4/30/2022
- 01142226A1
- Exp 7/13/2022
- b)10272101A1
- Exp 4/25/2022
- 11292137A1
- Exp 5/28/2022
- 12142120A2
- Exp 6/12/2022
- 01042235B
- Exp 7/3/2022
- 03012240A1
- Exp 8/28/2022
- 03042223A1
- Exp 8/31/2022.
Distribution
Distributed nationwide across the United States.
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