Agency classClass IIOur severity:Severe FDA (Drugs)·D-1536-2015·Announced 2015-09-23

FDA Recalls Hyaluronic Acid Injection Due to Sterility Concerns

The Compounding Pharmacy of America is recalling Hyaluronic Acid Sodium and Lidocaine HCl Injection due to GMP violations that may impact 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 injection product where sterility assurance is compromised, posing a significant risk of infection or serious injury.

Plain-English summary

The Compounding Pharmacy of America is recalling Hyaluronic Acid Sodium 35 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility.

The affected product was distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, specifically lot 04062015@66 (dated 7/5/2015) and lot 04072015@57 (dated 7/6/2015). The total quantity involved is 33 ml.

Consumers and healthcare providers should stop using the product and contact the recalling firm for further instructions or a refund.

The recalled product

Product: Hyaluronic Acid Sodium 35 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
Hazard: sterility
infection

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
04062015@66
7/5/2015
04072015@57
7/6/2015

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