RecallRadar

FDA Drug recall D-1457-2015

Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

On 2015-09-23 the FDA classified a Class II recall of Cyanocobalamin 1,000 mcg/ml, 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

AgencyFDA Drug
Recall numberD-1457-2015
ClassificationClass II
Statusterminated
Initiated2015-06-02
Published2015-09-23
Last updated2026-09-13 11:51 UTC
CompanyThe Compounding Pharmacy
DistributionUS

Product

Cyanocobalamin 1,000 mcg/ml, 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 05062015@2, 8/4/2015; 03182015@9, 6/16/2015; 03242015@9, 6/2…All lots distributed between November 2014 and May 2015 05062015@2, 8/4/2015; 03182015@9, 6/16/2015; 03242015@9, 6/22/2015; 03312015@72, 6/29/2015; 04152015@12, 7/14/2015; 04152015@13, 7/14/2015; 05052015@93, 8/3/2015; 05012015@35, 7/30/2015; 05072015@10, 8/5/2015

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-1457-2015%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.