FDA Recalls Compounded Hyaluronic Acid Injection Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Hyaluronic Acid Sodium and Lidocaine HCl Injection because an FDA inspection found GMP violations that may affect 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 involves a sterile injectable product where GMP violations pose a risk of serious health consequences, such as infection, which aligns with the 'Severe' criteria for significant injury risk.
Plain-English summary
The Compounding Pharmacy of America is voluntarily recalling Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, 20 ml syringes. The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product was distributed nationwide between November 2014 and May 2015. Specific lots involved in the recall include those with codes 03042015@6, 03122015@80, and 03262015@43.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Compounded 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 (7)
- All lots distributed between November 2014 and May 2015
- 03042015@6
- 6/2/2015
- 03122015@80
- 6/10/2015
- 03262015@43
- 6/24/2015
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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