Agency classClass IIOur severity:Severe FDA (Drugs)·D-1534-2015·Announced 2015-09-23

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: sterility
gmp-violation

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.

See all 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

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Same hazard · sterility