Agency classClass IIOur severity:Severe FDA (Drugs)·D-1739-2015·Announced 2015-09-23

MYO-DEN Injection Recalled for Potential Sterility and Quality Issues

The Compounding Pharmacy of America is recalling MYO-DEN Injection due to FDA inspection findings of GMP violations that may impact sterility and product quality.

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. According to the rubric, FDA Class II recalls involving potential sterility issues in injectable products are categorized as Severe (Score 4), particularly when structural or quality defects are identified by inspection.

Plain-English summary

The Compounding Pharmacy of America is recalling MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature. The recall involves 218 ml of product distributed nationwide. The affected lots were distributed between November 2014 and May 2015, specifically lot 02192015@44 (dated 5/20/2015) and lot 03162015@87 (dated 6/14/2015).

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. The agency classification for this recall is Class II.

Consumers and healthcare providers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on return or disposal. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product: MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable
Hazard: sterility
quality-defect

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
02192015@44
5/20/2015
03162015@87
6/14/2015

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