Agency classClass IIOur severity:High FDA (Drugs)·D-1696-2015·Announced 2015-09-23

Compounded MEGA-BURN Injection Recalled for Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling MEGA-BURN 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

The Compounding Pharmacy of America is recalling MEGA-BURN Injection, a sterile multi-dose vial product. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.

The affected product is MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature. The recall covers all lots distributed between November 2014 and May 2015. The distribution pattern is nationwide.

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for instructions on return or replacement.

The recalled product

Product: MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded Injectable
Hazard: sterility-failure
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 (20)

All lots distributed between November 2014 and May 2015
04212015@10
7/20/2015
02232015@86
5/24/2015
02252015@79
5/26/2015
03112015@21
6/9/2015
03232015@40
6/21/2015
03242015@76
6/22/2015
03312015@60
6/29/2015
03272015@27
6/25/2015
04022015@62
7/1/2015
04072015@55

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 →

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Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
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Same hazard · sterility failure