Ascorbic Acid Injectable Vials Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Ascorbic Acid 500 mg/ml Injectable Vials nationwide due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
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, which corresponds to a 'Severe' rating under the rubric for significant injury/property-damage reports or high-risk scenarios, though no specific injuries are reported in the text.
Plain-English summary
The Compounding Pharmacy of America is recalling Ascorbic Acid 500 mg/ml Injectable Vials, sterile multi-dose vials, distributed nationwide. The recall involves 2,923 mL of total volume across multiple lots distributed between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency cited a lack of assurance of sterility as the primary reason for the action.
Healthcare providers and patients should stop using the affected vials and contact the recalling firm for further instructions. The specific lot codes affected are listed in the official recall documentation.
The recalled product
- Product
- Ascorbic Acid 500 mg/ml Injectable Vial, Sterile Multi-Dose Vial, Refrigerate, 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 (18)
- All lots distributed between November 2014 and May 2015
- 05052015@1
- 8/3/2015
- 03112015@4
- 6/9/2015
- 03122015@32
- 6/10/2015
- 03122015@90
- 03232015@6
- 6/21/2015
- 03272015@38
- 6/25/2015
- 04072015@21
- 7/6/2015
- 05112015@75
- 8/9/2015
- 04222015@9
- 7/21/2015
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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