RecallRadar

FDA Drug recall D-1607-2015

Morphine 50 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 50 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-1607-2015
ClassificationClass II
Statusterminated
Initiated2015-06-02
Published2015-09-23
Last updated2026-09-13 11:51 UTC
CompanyThe Compounding Pharmacy
DistributionUS

Product

Morphine 50 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; 04142015@54, 6/13/2015; 04092015@68, 6/8/2015; 02252015@6, 5/…All lots distributed between November 2014 and May 2015; 04142015@54, 6/13/2015; 04092015@68, 6/8/2015; 02252015@6, 5/26/2015; 05042015@68, 7/3/2015; 03022015@20, 05/31/2015; 031192015@5, 6/9/2015; 03092015@22, 6/7/2015; 03122015@3, 6/10/2015; 03162015@81, 6/14/2015; 03242015@74, 6/22/2015, 03302015@64, 6/28/2015; 04062015@46, 7/5/2015; 04212015@25, 6/20/2015; 04222015@18, 6/21/2015, 04242015@56, 6/23/2015; 04272015@29, 6/26/2015; 05012015@18, 6/30/2015; 05082015@32, 7/7/2015

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-1607-2015%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.