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

Famotidine injection syringe a) 10 mg/ b) 80 mg recalled

Walgreens Infusion Services is recalling Famotidine injection syringe a) 10 mg/ b) 80 mg, 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 recalled21 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-0546-2016
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

Timeline

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

Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Where it was distributed

Texas

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.

ReportedClassRecallCompanyReasonWhere
CLASS II0.9% NaCl with Ca 4.65 meq recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX
CLASS II0.9% Sodium Chloride/MVI injection recalledWalgreens Infusion ServicesSterilityTX
CLASS IIOxacillin/NS-24 hr Accuflo recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX
CLASS IIInvanz/NS Minibag Plus recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX
CLASS IIGentamicin 14.4 mg/sodium chloride 0.9% Prefilled syringe recalledWalgreens Infusion ServicesSterilityTX
CLASS IIPhytonadione (Vitamin K) 1 mg/ Syringe recalledWalgreens Infusion ServicesSterilityTX
CLASS IIPiperacillin/Tazobactam (Zosyn) Accuflo, a)/NS b)/NS Accuflo recalledWalgreens Infusion ServicesSterilityTX
CLASS IIL-Cysteine 800 mg syringe recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX
CLASS IITobramycin 620 mg/NS Accuflo recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX
CLASS IIPrimaxin (Imipenem-Cilastatin) 500 mg/NS Minibag Plus recalledWalgreens Infusion ServicesSterilityTX
CLASS IIIVIG Gammagard injection, a) 13 gm, b) 20 gm, c) 73 gm recalledWalgreens Infusion ServicesSterilityTX
CLASS IIFolic Acid 1 mg/ syringe recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX
CLASS IIDextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq recalledWalgreens Infusion ServicesSterilityTX
CLASS IIIVIG Gamunex 40 gm recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX
CLASS IIVancomycin Injection in NS, Accuflo, a) 500 mg/NS, b)/NS recalledWalgreens Infusion ServicesSterilityTX
CLASS IINafcillin 12 gm in NS recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX
CLASS IIDextrose 5% and 0.9% Sodium Chloride injection bag a), b) recalledWalgreens Infusion ServicesSterilityTX
CLASS IICeftriaxone/NS Minibag Plus recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX
CLASS IIHeparin injection, Preservative Free, a), b) syringe, c) recalledWalgreens Infusion ServicesSterilityTX
CLASS IIMeropenem/NS Minibag Plus recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX
CLASS II0.9% Sodium Chloride injection, a), b) c) recalledWalgreens Infusion ServicesSterilityTX
CLASS II1 TPN formula daily+overfill recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX
CLASS IIClindamycin injection, Accuflo, a) 500 mg/NS b) 900 mg/NS recalledWalgreens Infusion ServicesSterilityTX
CLASS IIRemicade (Infliximab) injection, 5 mg/kg recalledWalgreens Infusion ServicesSterilityTX
CLASS IISodium Ascorbate (Vitamin C) syringe, a) 500 mg/ syringe recalledWalgreens Infusion ServicesSterilityTX
CLASS IIMilrinone 0.375 mcg/kg/min D5W bag a), b) c) recalledWalgreens Infusion ServicesSterilityTX
CLASS IIInsulin Regular (Human) syringe, a), b) syringe, c) recalledWalgreens Infusion ServicesSterilityTX
CLASS IIThiamine 100 mg syringe recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX
CLASS IITeflaro 600 mg in NS Minibag Plus recalledWalgreens Infusion ServicesSterilityTX
CLASS IICefepime/NS Minibag Plus recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX
CLASS IICefazolin in Accuflo, a)/NS, b)/NS, c)/NS recalledWalgreens Infusion ServicesSterilityTX
CLASS IIPedi MVI a), b) syringe recalled by Walgreens Infusion ServicesWalgreens Infusion ServicesSterilityTX

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