Agency classClass IIOur severity:Severe FDA (Drugs)·D-1687-2015·Announced 2015-09-23

Compounding Pharmacy Recalls LIPO-Tropic Injectable Due to Sterility Concerns

The Compounding Pharmacy of America is recalling LIPO-Tropic Injectable vials because FDA inspections found violations that may affect 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving potential sterility failures in injectable products are categorized as Severe (Score 4) due to the significant risk of infection or injury.

Plain-English summary

The Compounding Pharmacy of America is recalling LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature. The product was distributed nationwide between November 2014 and May 2015. The recall involves 305 ml vials.

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

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

The recalled product

Product: LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable
Hazard: sterility-failure
infection-risk

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
02262015@3
5/27/2015

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 failure