Agency classClass IIOur severity:Severe FDA (Drugs)·D-1538-2015·Announced 2015-09-23

Hyaluronidase Injection Recalled for Lack of Sterility Assurance

The Compounding Pharmacy of America is recalling Hyaluronidase 150 units/ml Injection due to FDA inspection findings of GMP violations that 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 the source text explicitly states that GMP violations potentially impact product sterility, which aligns with the rubric criteria for Severe severity involving significant risk factors.

Plain-English summary

The Compounding Pharmacy of America is recalling Hyaluronidase 150 units/ml Injection, a sterile, preserved, refrigerated product. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility.

The affected product is distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and dates include 04132015@19 (7/12/2015), 02202015@12 (5/21/2015), and 05112015@17 (8/9/2015).

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the medication.

The recalled product

Product: Hyaluronidase 150 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable
Hazard: sterility
gmp-violations

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
04132015@19
7/12/2015
02202015@12
5/21/2015
05112015@17
8/9/2015

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

See all →

Critical
FDA Recalls Non-Sterile HCG and Methylcobalamin Injection Vials
FDA (Drugs) · 2018-02-21
Severe
FDA Recalls Morphine and Ropivacaine Compounded Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
Severe
Hydromorphone Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
Severe
Morphine and Bupivacaine Solution Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
Severe
Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23

Same hazard · sterility