RecallRadar

FDA Drug recall D-1585-2015

Morphine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

On 2015-09-23 the FDA classified a Class II recall of Morphine 10 mg/ml Solution, Sterile-Preservative Free, 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-1585-2015
ClassificationClass II
Statusterminated
Initiated2015-06-02
Published2015-09-23
Last updated2026-09-13 11:51 UTC
CompanyThe Compounding Pharmacy
DistributionUS

Product

Morphine 10 mg/ml Solution, Sterile-Preservative Free, 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; 02252015@1, 5/26/2015; 03062015@38, 6/4/2015; 03162015@77, 6/…All lots distributed between November 2014 and May 2015; 02252015@1, 5/26/2015; 03062015@38, 6/4/2015; 03162015@77, 6/14/2015; 03242015@44, 6/22/2015; 03242015@51, 6/22/2015; 04072015@58, 7/6/2015; 04132015@6, 6/12/2015; 04142015@60, 6/13/2015; 04222015@12, 6/21/2015; 05122015@16, 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-1585-2015%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.