Hyaluronic Acid Injection Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Hyaluronic Acid Sodium and Lidocaine HCl Injection 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 recall is classified as FDA Class II and involves a sterile injection product with potential sterility failures, which aligns with the rubric criterion for 'FDA Class II with hospitalization reports' or significant injury risk, warranting a score of 4.
Plain-English summary
The Compounding Pharmacy of America is recalling Hyaluronic Acid Sodium 32 mg/ml + Lidocaine HCl 3 mg/ml Injection, 8 ml Syringe. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is sterile and intended for room temperature storage. It was distributed nationwide between November 2014 and May 2015. Specific lot codes identified in the recall include 03232015@42 (expiration 6/21/2015) and 03252015@25 (expiration 6/23/2015).
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for instructions on return or replacement. The FDA classifies this recall as Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Hyaluronic Acid Sodium 32 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 — Injectable
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
- 03232015@42
- 6/21/2015
- 03252015@25
- 6/23/2015
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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