Compounded 5-Methyl Tetrahydrofolate Injectable Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling 5-Methyl Tetrahydrofolate injectable vials due to GMP violations that may impact sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
The Compounding Pharmacy of America is recalling 351 mL of 5-Methyl Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vials. The product was distributed nationwide between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations raise a lack of assurance regarding the sterility of the product, potentially impacting its quality.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- 5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable
- Hazard
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)
- All lots distributed between November 2014 and May 2015
- 02232015@75
- 5/24/2015
- 03042015@22
- 6/2/2015
- 03172015@44
- 6/15/2015
- 03192015@21
- 6/17/2015
- 03232015@61
- 6/21/2015
- 03272015@49
- 6/25/2015
- 04132015@50
- 7/12/2015
- 04132015@54
- 7/12/201
- 04152015@35
- 7/14/2015
- 04162015@12
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America 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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