Agency classClass IIOur severity:Severe FDA (Drugs)·D-1463-2015·Announced 2015-09-23

DMPS Injectable Recalled for Lack of Sterility Assurance

The Compounding Pharmacy of America is recalling DMPS injectable vials 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 involves a lack of sterility assurance in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

The Compounding Pharmacy of America is recalling DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dose Vials. The product is sterile, refrigerated, and has a total volume of 30 mL. The recall covers all lots distributed between November 2014 and May 2015, including lot 04222015@67 dated 7/21/2015. The product was distributed nationwide.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, resulting in a lack of assurance of sterility. The agency has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected DMPS injectable vials immediately. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product: DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable
Hazard: lack-of-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 (3)

All lots distributed between November 2014 and May 2015
04222015@67
7/21/2015

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 · lack of sterility