RecallRadar

FDA Drug recall D-0711-2021

HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML,…

On 2021-08-18 the FDA classified a Class I recall of HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML,… by Med Shop Total Care, citing non-Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0711-2021
ClassificationClass I
Statusterminated
Initiated2020-10-05
Published2021-08-18
Last updated2026-09-13 11:52 UTC
CompanyMed Shop Total Care
DistributionPR, TX

Product

HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Reason

Non-Sterility

Identifiers

code_info
Lot #: a) 09282020@66, BUD 10/27/2020, 09302020@42, BUD 10/29/2020, b) 09282020@79, c) 09292020@32, BUD 10/27/2020…Lot #: a) 09282020@66, BUD 10/27/2020, 09302020@42, BUD 10/29/2020, b) 09282020@79, c) 09292020@32, BUD 10/27/2020 09282020@66 09302020@42 09282020@79 09292020@32 10/27/2020 10/29/2020 10/27/2020 10/27/2020

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0711-2021%22

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