CLASS II Drug recall · Reported 5 Nov 2014 · FDA Enforcement Report

Acetylcysteine 10% (PF) inhalant solution recalled

Martin Avenue Pharmacy is recalling Acetylcysteine 10% (PF) inhalant solution, distributed nationwide in the US. The recall was initiated on 27 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 08072014@64, Exp 9/6/2014
Quantity recalled1440 mL

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-0054-2015
FDA event ID
69152
Recalling firm
Martin Avenue Pharmacy, Naperville, IL
Classification
Class II
Status
Terminated
Recall initiated
27 Aug 2014
FDA classified
29 Oct 2014
Reported
5 Nov 2014
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Sterility

Timeline

27 Aug 2014Recall initiated by company
29 Oct 2014Classified by FDA+63 days
5 Nov 2014Published 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: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

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

Acetylcysteine 10% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Which lots are affected?

Lot Number: 08072014@64, Exp 9/6/2014

Where was it sold?

Nationwide

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

100 other products · FDA event 69152

This product is part of a recall event; the main page for the event is Phentolamine mesylate 5 mg/35 mg/mannitol trituration recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIPhentolamine mesylate 5 mg/35 mg/mannitol trituration recalledMartin Avenue PharmacySterilityNationwide
CLASS IIQuad mix, 9 mg/1 mg/10 mcg/0.1 mg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIHyaluronidase injection solution (PF) 150 U/mL injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IIBenzalkonium chloride water for injection recalledMartin Avenue PharmacySterilityNationwide
CLASS IIHydroxyzine hydrochloride 25 mg/mL injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IIVoriconazole 10 mg/mL opthalmic solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IIFentanyl injectable 6000 mcg/mL recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIQuad mix 2, 12 mg/1 mg/25 mcg/0.25 mg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIQuad mix, 18 mg/0.2 mg/10 mcg/0.02 mg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIPhenol 10% injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIMethylcobalamin 25 mg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIChorionic gonadotropin/mannitol 10000 U/0.1 gm powder recalledMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix T50, 8.825 mg/0.29 mg/2.95 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIVancomycin 50 mg/mL opthalmic solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix ST2, 30 mg/3 mg/100 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIRescue solution with triamcinolone (lidocaine, bupivacaine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIAtropine sulfate 0.01% opthalmic solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IIHistamine 0.55 mg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIMethylcobalamin 1 mg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIDexamethasone sodium phosphate 4 mg/mL injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IIOpthalmic ointment base ointment recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIHydromorphone HCl (PF) 1 mg/mL injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IISodium tetradecyl sulfate 3% (PF) injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IIAtropine sulfate 2 mg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIMethylcobalamin (PF) 1 mg/mL injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix, 30 mg/1 mg/20 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix ST9-B, 30 mg/2 mg/100 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIPhenylephrine 10% opthalmic solution recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIQuad mix, 30 mg/1 mg/10 mcg/0.15 mg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIMorphine sulfate (PF) 3 mg/mL injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IIHydromorphone HCl/bupivacaine (PF) 10 mg/7.5 mg/mL injection recalledMartin Avenue PharmacySterilityNationwide
CLASS IISodium tetradecyl sulfate 5% (PF) injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IILidocaine (PF) 1% injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIQuad mix, 30 mg/1 mg/20 mcg/0.15 mg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIAlprostadil alcohol 500 mcg/mL injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IILidocaine 1% injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix ST1, 30 mg/1.5 mg/50 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIPhenylephrine 1% injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IISodium tetradecyl sulfate 1% (PF) injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IITacrolimus oil 0.03% opthalmic solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IITetracycline 250 mg powder kits packaged with powder recalledMartin Avenue PharmacySterilityNationwide
CLASS IITestosterone cypionate 250 mg/mL injection recalledMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix, 30 mg/3 mg/5 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIPGE 20 mcg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIChorionic gonadotropin buffered diluent solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IIHydrochloric acid/water for injection 10% (w/v) recalledMartin Avenue PharmacySterilityNationwide
CLASS IICyclosporine suspending vehicle recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IISodium tetradecyl SO4 stock solution 6% solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IIMorphine sulfate (PF) 20 mg/mL injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IITestosterone cypionate 200 mg/mL injection recalledMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix T108, 30 mg/1.5 mg/25 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IITobramycin (PF) 15 mg/mL opthalmic solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IIPGE 3, 200 mcg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix T105, 30 mg/1 mg/10 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIAtropine sulfate 1 mg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix ST5, 30 mg/1.5 mg/300 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIHyaluronidase base vehicle (PF) solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IIFentanyl injectable 2000 mcg/mL recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix SEST 4, 30 mg/1.5 mg/400 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS II"NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix ST9-E, 30 mg/4 mg/150 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IITriamcinolone acetonide suspending vehicle (PF) vehicle recalledMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix 8.3 low dose, 22 mg/0.83 mg/8.3 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IITestosterone cypionate 150 mg/mL injection recalledMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix T101, 17.65 mg/0.59 mg/5.9 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIMethylcobalamin 10 mg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIMorphine/bupivacaine 5 mg/2 mg/mL injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IIVancomycin 25 mg/mL opthalmic solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IIMethylcobalamin (PF) 25 mg/mL injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IIPGE 4, 300 mcg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IICromolyn sodium 1% inhalant solution recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIHydroxocobalamin 10 mg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIHydromorphone/clonidine/bupivacaine 12 mg/600 mcg/0.2 mg/mL recalledMartin Avenue PharmacySterilityNationwide
CLASS IIPGE 2.5, 150 mcg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIAtropine sulfate 0.5% opthalmic solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IIGlycerin 72% (w/v) sodium chloride injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IIPeng/proc/strep/chlor/hyos (penicillin G, procaine recalledMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix T102, 17.65 mg/0.59 mg/10 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIDexamethasone sodium phosphate 24 mg/mL injectable recalledMartin Avenue PharmacySterilityNationwide
CLASS IIParaben water for injection recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix, 30 mg/0.5 mg/10 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIAcetylcysteine 20% (PF) inhalant solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IIPolyhexamethylene biguanide 2% stock solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IITrimethoprim/sulfadiazine excipient stock solution injection recalledMartin Avenue PharmacySterilityNationwide
CLASS IIQuad mix 1, 12 mg/1 mg/10 mcg/0.15 mg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIPolyhexamethylene biguanide 0.02% opthalmic solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IICyclosporine 200 mg/mL opthalmic suspension recalledMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix, 30 mg/2 mg/10 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIAcetylcysteine 10% opthalmic solution recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIPGE 2, 100 mcg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IICyanocobalamin 1000 mcg/mL injectable solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IICefazolin forte 50 mg/mL opthalmic solution recalledMartin Avenue PharmacySterilityNationwide
CLASS IIDiazepam 5 mg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IILidocaine 2% injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIPGE 1, 40 mcg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IIHydroxocobalamin 5 mg/mL injectable recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix ST9-A, 30 mg/2 mg/80 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix, 12 mg/1 mg/9 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IITri-mix, 30 mg/2 mg/20 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
CLASS IIPilocarpine (PF) 0.25% opthalmic solution recalledMartin Avenue PharmacySterilityNationwide

More recalls from Martin Avenue Pharmacy

All 118
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIDihydroergotamine mesylate 1 mg/mL injection solution recalledMartin Avenue PharmacySterilityNationwide
DrugCLASS IINalbuphine 10 mg/mL injection solution recalledMartin Avenue PharmacySterilityNationwide
DrugCLASS IIFentanyl/bupivacaine 3000 mcg/30 mg/mL injectable recalledMartin Avenue PharmacySterilityNationwide
DrugCLASS IITri-mix, 15 mg/0.5 mg/10 mcg/mL (papaverine recalledMartin Avenue PharmacySterilityNationwide
DrugCLASS IIBacteriostatic water for injection recalled by Martin Avenue PharmacyMartin Avenue PharmacySterilityNationwide

Other Acetylcysteine (pf) Inhalant recalls

All 2
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIAcetylcysteine 20% (PF) inhalant solution recalledMartin Avenue PharmacySterilityNationwide