Agency classClass IIOur severity:Severe FDA (Drugs)·D-1629-2015·Announced 2015-09-23

Sermorelin Injection Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Sermorelin 1000 mcg/ml Injection due to FDA inspection findings of 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving potential sterility issues in injectable products are classified as Severe (Score 4) due to the significant risk of infection or injury, even without explicit reports of hospitalization in the provided text.

Plain-English summary

The Compounding Pharmacy of America is recalling Sermorelin 1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE. The recall covers 77 ml vials distributed nationwide between November 2014 and May 2015. Specific lots affected include 04092015@84, 04062015@55, 04222015@104, and 04292015@47.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations raise concerns regarding the assurance of sterility and potentially impact the overall quality of the product.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or return.

The recalled product

Product: Sermorelin 1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — 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 (9)

All lots distributed between November 2014 and May 2015
04092015@84
6/8/2015
04062015@55
6/5/2015
04222015@104
6/21/2015
04292015@47
6/28/2015

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