FDA Drug recall D-1631-2015

Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knox…

FDA Drug
Class II
terminated
Published 2015-09-23

On 2015-09-23 the FDA classified a Class II recall of Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knox… 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-1631-2015
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

Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, 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; 05072015@31, 7/6/2015; 03232015@11, 5/22/2015; 03302015@44,… All lots distributed between November 2014 and May 2015; 05072015@31, 7/6/2015; 03232015@11, 5/22/2015; 03302015@44, 5/29/2015; 03272015@16, 5/26/2015; 04222015@81, 6/1/2015; 04032015@15, 6/2/2015; 04142015@9, 6/13/2015; 04232015@11, 6/22/2015; 04272015@42, 6/26/2015; 04292015@86, 6/28/2015

code_info

All lots distributed between November 2014 and May 2015; 05072015@31, 7/6/2015; 03232015@11, 5/22/2015; 03302015@44,…

All lots distributed between November 2014 and May 2015; 05072015@31, 7/6/2015; 03232015@11, 5/22/2015; 03302015@44, 5/29/2015; 03272015@16, 5/26/2015; 04222015@81, 6/1/2015; 04032015@15, 6/2/2015; 04142015@9, 6/13/2015; 04232015@11, 6/22/2015; 04272015@42, 6/26/2015; 04292015@86, 6/28/2015

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-1631-2015%22

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