Pyridoxine Hydrochloride Injectable Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Pyridoxine Hydrochloride 100 mg/ml Injectable due to FDA inspection findings of 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 source text identifies the recall as FDA Class II and cites GMP violations impacting sterility, which aligns with the rubric criterion for Severe (Score 4) involving significant quality defects in medical products.
Plain-English summary
The Compounding Pharmacy of America is recalling Pyridoxine Hydrochloride 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, Protect from Light. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is a 196 ml total volume multi-dose vial. All lots distributed between November 2014 and May 2015 are included in this recall. Specific lot codes and dates include 03122015@6/102015, 03202015@29, 6/18/2015, and 03232015@3, 6/21/2015. The product was distributed nationwide.
Healthcare providers and patients should stop using the recalled product and contact the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Pyridoxine Hydrochloride 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, Protect from Light, 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 (5)
- All lots distributed between November 2014 and May 2015 03122015@6/102015
- 03202015@29
- 6/18/2015
- 03232015@3
- 6/21/2015
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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