FDA Drug recall D-1569-2015

Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, 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 Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, 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-1569-2015
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

Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, 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; 03022015@86, 5/31/2015; 04012015@71, 6/30/2015; 02202015@43,… All lots distributed between November 2014 and May 2015; 03022015@86, 5/31/2015; 04012015@71, 6/30/2015; 02202015@43, 5/21/2015,; 2232015@74, 5/24/2015; 02272015@70, 5/28/2015; 03052015@8, 6/3/2015; 03102015@61, 6/8/2015; 03092015@97, 6/7/2015; 03202015@98, 6/18/2015; 03232015@62, 6/21/2015; 03272015@50, 6/25/2015; 03312015@47, 6/29/2015; 04022015@20, 7/1/2015; 04062015@1, 7/5/2015; 04062015@61, 7/5/2015; 04132015@49, 7/12/2015; 04132015@53, 7/12/2015; 04152015@26, 7/14/2015; 04162015@20, 7/15/2015; 04222015@41, 7/21/2015; 04162015@50, 7/15/2015; 05012015@52, 7/30/2015; 04242015@64, 7/1/2015; 04302015@3, 7/29/2015; 04302015@40, 7/29/2015; 04302015@43, 7/29/2015; 04292015@99, 7/28/2015; 05062015@19, 8/4/2015; 05122015@14, 7/11/2015

code_info

All lots distributed between November 2014 and May 2015; 03022015@86, 5/31/2015; 04012015@71, 6/30/2015; 02202015@43,…

All lots distributed between November 2014 and May 2015; 03022015@86, 5/31/2015; 04012015@71, 6/30/2015; 02202015@43, 5/21/2015,; 2232015@74, 5/24/2015; 02272015@70, 5/28/2015; 03052015@8, 6/3/2015; 03102015@61, 6/8/2015; 03092015@97, 6/7/2015; 03202015@98, 6/18/2015; 03232015@62, 6/21/2015; 03272015@50, 6/25/2015; 03312015@47, 6/29/2015; 04022015@20, 7/1/2015; 04062015@1, 7/5/2015; 04062015@61, 7/5/2015; 04132015@49, 7/12/2015; 04132015@53, 7/12/2015; 04152015@26, 7/14/2015; 04162015@20, 7/15/2015; 04222015@41, 7/21/2015; 04162015@50, 7/15/2015; 05012015@52, 7/30/2015; 04242015@64, 7/1/2015; 04302015@3, 7/29/2015; 04302015@40, 7/29/2015; 04302015@43, 7/29/2015; 04292015@99, 7/28/2015; 05062015@19, 8/4/2015; 05122015@14, 7/11/2015

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-1569-2015%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.