CLASS II Drug recall · Reported 6 Jan 2016 · FDA Enforcement Report

Gentamicin 14.4 mg/sodium chloride 0.9% Prefilled syringe recalled

Walgreens Infusion Services is recalling Gentamicin 14.4 mg/sodium chloride 0.9% Prefilled syringe, distributed in Texas. The recall was initiated on 10 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots within expiry.

Quantity recalled27 syringes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0549-2016
FDA event ID: 72594
Recalling firm: Walgreens Infusion Services, San Antonio, TX
Classification: Class II
Status: Terminated
Recall initiated: 10 Nov 2015
FDA classified: 30 Dec 2015
Reported: 6 Jan 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

10 Nov 2015	Recall initiated by company
30 Dec 2015	Classified by FDA	+50 days
6 Jan 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Where it was distributed

Texas

Stores named: Walgreens

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

All lots within expiry.

Where was it sold?

Texas

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

32 other products · FDA event 72594

This product is part of a recall event; the main page for the event is 0.9% NaCl with Ca 4.65 meq recalled by Walgreens Infusion Services.

Reported	Class	Recall	Company	Reason	Where
6 Jan 2016	CLASS II	0.9% NaCl with Ca 4.65 meq recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	0.9% Sodium Chloride/MVI injection recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Oxacillin/NS-24 hr Accuflo recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Invanz/NS Minibag Plus recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Phytonadione (Vitamin K) 1 mg/ Syringe recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Piperacillin/Tazobactam (Zosyn) Accuflo, a)/NS b)/NS Accuflo recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	L-Cysteine 800 mg syringe recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Tobramycin 620 mg/NS Accuflo recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Primaxin (Imipenem-Cilastatin) 500 mg/NS Minibag Plus recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	IVIG Gammagard injection, a) 13 gm, b) 20 gm, c) 73 gm recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Folic Acid 1 mg/ syringe recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	IVIG Gamunex 40 gm recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Vancomycin Injection in NS, Accuflo, a) 500 mg/NS, b)/NS recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Famotidine injection syringe a) 10 mg/ b) 80 mg recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Nafcillin 12 gm in NS recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Dextrose 5% and 0.9% Sodium Chloride injection bag a), b) recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Ceftriaxone/NS Minibag Plus recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Heparin injection, Preservative Free, a), b) syringe, c) recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Meropenem/NS Minibag Plus recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	0.9% Sodium Chloride injection, a), b) c) recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	1 TPN formula daily+overfill recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Clindamycin injection, Accuflo, a) 500 mg/NS b) 900 mg/NS recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Remicade (Infliximab) injection, 5 mg/kg recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/ syringe recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Milrinone 0.375 mcg/kg/min D5W bag a), b) c) recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Insulin Regular (Human) syringe, a), b) syringe, c) recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Thiamine 100 mg syringe recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Teflaro 600 mg in NS Minibag Plus recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Cefepime/NS Minibag Plus recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Cefazolin in Accuflo, a)/NS, b)/NS, c)/NS recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016	CLASS II	Pedi MVI a), b) syringe recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX

More recalls from Walgreens Infusion Services

All 69

Reported	Class	Recall	Company	Reason	Where
6 Jan 2016Drug	CLASS II	Pedi MVI a), b) syringe recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016Drug	CLASS II	Cefazolin in Accuflo, a)/NS, b)/NS, c)/NS recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016Drug	CLASS II	Cefepime/NS Minibag Plus recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX
6 Jan 2016Drug	CLASS II	Teflaro 600 mg in NS Minibag Plus recalled	Walgreens Infusion Services	Sterility	TX
6 Jan 2016Drug	CLASS II	Thiamine 100 mg syringe recalled by Walgreens Infusion Services	Walgreens Infusion Services	Sterility	TX

Other Gentamicin recalls

All 27

Reported	Class	Recall	Company	Reason	Where
25 Jun 2025Drug	CLASS II	Gentamicin Injection, USP, (Pediatric), 20 mg recalled by Eugia USGentamicin	Eugia US	Potency & Assay	Nationwide
30 Mar 2022Drug	CLASS II	Gentamicin Sulfate Cream recalled by Teligent Pharma	Teligent Pharma	Potency & Assay	Nationwide
30 Mar 2022Drug	CLASS II	Gentamicin Sulfate Cream recalled by Teligent Pharma	Teligent Pharma	Potency & Assay	Nationwide
30 Mar 2022Drug	CLASS II	Gentamicin Sulfate Ointment USP 0.1%, packaged as a) tube recalled	Teligent Pharma	Potency & Assay	Nationwide
8 Apr 2020Drug	CLASS II	Gentamicin 80mg/ Irrigation, containers recalled	The Medicine Shoppe Pharmacy	Sterility	FL