FDA Drug recall D-1696-2015

MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

FDA Drug
Class II
terminated
Published 2015-09-23

On 2015-09-23 the FDA classified a Class II recall of MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN by The Compounding Pharmacy, citing lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1696-2015
Classification	Class II
Status	terminated
Initiated	2015-06-02
Published	2015-09-23
Last updated	2026-09-13 11:51 UTC
Company	The Compounding Pharmacy
Distribution	US

Product

MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Reason

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Identifiers

code_info	All lots distributed between November 2014 and May 2015; 04212015@10, 7/20/2015; 02232015@86, 5/24/2015; 02252015@79,… 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, 7/6/2015; 04142015@59, 7/13/2015; 04212015@30, 7/20/2015; 04212015@54, 7/20/2015; 04222015@31, 7/21/2015; 05042015@64, 8/2/2015; 05052015@60, 8/3/2015; 04272015@77, 7/26/2015; 04292015@14, 7/28/2015; 04292015@23, 7/28/2015; 05052015@92, 8/3/2015; 05082015@23, 8/6/2015; 05012015@11, 7/30/2015; 05052015@98, 8/3/2015

code_info

All lots distributed between November 2014 and May 2015; 04212015@10, 7/20/2015; 02232015@86, 5/24/2015; 02252015@79,…

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, 7/6/2015; 04142015@59, 7/13/2015; 04212015@30, 7/20/2015; 04212015@54, 7/20/2015; 04222015@31, 7/21/2015; 05042015@64, 8/2/2015; 05052015@60, 8/3/2015; 04272015@77, 7/26/2015; 04292015@14, 7/28/2015; 04292015@23, 7/28/2015; 05052015@92, 8/3/2015; 05082015@23, 8/6/2015; 05012015@11, 7/30/2015; 05052015@98, 8/3/2015

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1696-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.