CLASS II Drug recall · Reported 18 Sep 2013 · FDA Enforcement Report

Nalbuphine HCL 20 MG/ML Injectable, all presentations recalled

Beacon Hill Medical Pharmacy, P.C is recalling Nalbuphine HCL 20 MG/ML Injectable, all presentations, For Intraveno and SQ Use Only, distributed nationwide in the US. The recall was initiated on 26 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes03282013@8, 02282013@2, 04012013@22, 05022013@22, 05012013@38
Quantity recalledN/A

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-983-2013
FDA event ID
65876
Recalling firm
Beacon Hill Medical Pharmacy, P.C, Southfield, MI
Classification
Class II
Status
Terminated
Recall initiated
26 Jul 2013
FDA classified
10 Sep 2013
Reported
18 Sep 2013
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Sterility

Timeline

26 Jul 2013Recall initiated by company
10 Sep 2013Classified by FDA+46 days
18 Sep 2013Published in enforcement report+8 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; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted 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

NALBUPHINE HCL 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

Where it was distributed

USA nationwide

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Which lots are affected?

03282013@8, 02282013@2, 04012013@22, 05022013@22, 05012013@38

Where was it sold?

USA 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

85 other products · FDA event 65876

This product is part of a recall event; the main page for the event is Estradiol Cyp/Prog/Test Cyp 0.5/10/10 MG/ML Oil Inj Soln recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIEstradiol Cyp/Prog/Test Cyp 0.5/10/10 MG/ML Oil Inj Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIHydroxocobalamin (Vitamin B12A) 1 MG/ML Injectable recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIParaben Water For Injection, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIAscorbic Acid ( non-Corn Source) 500 MG/ML Injectable recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIGlutathione 200 MG/ML (PF) Inj Soln, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIGlutathione/Lido 100MG/2%/ML (PF) Inj Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IITriamcinolone Acetonide 80 MG/ML Inj Susp recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIOxytocin/ML, all presentations recalled by Beacon Hill Medical PharmacyBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIZinc Sulfate 1 mg/ml Injectable, all configurations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIMagnesium Chloride Hexahydrate 20% Injectable recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IICalcium Edta 200 MG/ML Injectable, all configurations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIGlycyrrhizic Acid 8 MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIQuad Amino Blend 150/75/150/75 MG/ML Injectable recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IICalcium Chloride 100 MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIB-12/Lidocaine 25/10MG/ML, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIMethylprednisolone Acetate 40 MG/ML and 80 MG/ML Injectable recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIDmps 50mg/ml Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IICalcium Edta 300 MG/ML Injectable, all configurations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IILidocaine Mdv 1% Injectable recalled by Beacon Hill Medical PharmacyBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIProg/Test Cyp 15/7.5 MG/ML Oil Inj Soln, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IILipo-plex Injectable, all presentations, For Intraveno recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIMultitrace-5 Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIBi-tropin S-2 Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIDexamethasone Sodium Phosphate 10 MG/ML Injectable recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIProgesterone 50 MG/ML Oil Inj Soln, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIPhosphatidylcholine 50 MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIEstradiol Valerate W/ Lidocaine 1% 40 MG/ML Oil Inj Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIBuprenorphine 0.1/0.05 MG/ML Cream, all configurations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIProcaine P/F 20 MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIFreamine Iii Alt recalled by Beacon Hill Medical PharmacyBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IITri-mix 10 Mcg/30 MG/1 MG/ML Inj Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIKetorolac Tromethamine 60 MG/ML Injectable recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IICopper 0.4MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIB12/E2/E3/Prog/Test 1/3.75/2.5/50/45 MG/ML Oil Inj Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IITriptropin Plus Injectable, all configurations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIAlprostadil, 50 Mcg/ML Inj Soln, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIFurosemide 10 MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIAcetylcysteine 100 MG/ML Inj Soln, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIHydrogen Peroxide 3% Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIDextrose PF 50% Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIDmso 50% Inj Vial Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIB-complex/Lidocaine 2% Injection, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIVitamin D 50,000 I.U./ML Injectable, all configurations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IITestosterone Propionate 100 MG/ML Oil Inj Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IITriple-testosterone 250 MG/ML Oil Inj Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIBi-mix Phentolamine/Papaverine 0.5 MG/30 MG/ML recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIPotassium Chloride 2 Meq/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IITestosterone Cypionate 100 MG/ML, 200 MG/ML recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIH.C.G. (Compounded), 5,000, 8 recalled by Beacon Hill Medical PharmacyBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIAlprostadil 100 Mcg/ML Inj Soln, all sizes recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIPumice/Lidocaine HCL 1.5%/1% Inj Susp, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIHydroxyprogesterone Caproate 250 MG/ML Oil Inj Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIB-complex/Lido/B-12, 25MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IICyanocobalamin 1000 Mcg/ML Inj Soln, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IISodium Hydroxide 10% (W/V)/Water For Injection recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIEstriol 5 MG/ML Oil Inj Soln, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IISelenium 400 Mcg/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIMic-carn + B6/B12/Lidocaine 25/50/50/175MCG/1/0.1MG/ML recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IITestosterone Hypoallergenic 200 MG/ML Injectable recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIArginine (R-gene) 100 MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIL-tryptophan 300 MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IILipoic Acid 100 MG/ML and 200 MG/ML Injectable recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IINandrolone Decanoate 100 MG/ML and 200 MG/ML Oil Inj Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIGlutamine 100 MG/ML Inj Soln, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIManganese Sulfate 0.1 MG/ML Injectable, all configurations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIGlutathione/Methyl/Lido 100/25/20 MG/ML Inj Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIChromium 4 Mcg/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIMethylcobalamin 1 mg/ml, 5 mg/ml, 10 mg/ml, 25 mg/ml recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IISodium Phosphate Dibasic/Water For Injection recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIMagnesium Sulfate 50% Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IINaltrexone 1 MG/ML Injectable and 200 MG/ML Injectable recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIGlycine 50 MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIAscorbic Acid (Corn Source) 500 MG/ML Injectable recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIVitamin B-complex Injectable, Vitamin B-complex SL Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIPyridoxine HCL P/F 100 MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IISermorelin Acetate 10 MG Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIDual-testosterone 20, 50, 100, 150, 200 MG/ML Oil Inj Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIHyaluronidase 150 U/ML and 200 U/ML Injectable recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIDexpanthenol 250 MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIMic-carn Max 15/100/50/1 MG/ML Injectable recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIEstradiol Cypionate 5, 10, 40 MG/ML Oil Inj Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIEdetate Disodium 150 MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IISodium Phosphate Monobasic/Water For Injection recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IISodium Bicarbonate PF 8.4% Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
CLASS IIB-12 Rejuv 25 MG/ML Injectable, all configurations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide

More recalls from Beacon Hill Medical Pharmacy, P.C

All 86
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIB-12 Rejuv 25 MG/ML Injectable, all configurations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
DrugCLASS IISodium Bicarbonate PF 8.4% Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
DrugCLASS IISodium Phosphate Monobasic/Water For Injection recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
DrugCLASS IIEdetate Disodium 150 MG/ML Injectable, all presentations recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide
DrugCLASS IIEstradiol Cypionate 5, 10, 40 MG/ML Oil Inj Soln recalledBeacon Hill Medical Pharmacy, P.CSterilityNationwide

Other Nalbuphine recalls

All 3
ReportedClassRecallCompanyReasonWhere
DrugCLASS IINalbuphine 10 mg/mL injection solution recalledMartin Avenue PharmacySterilityNationwide
DrugCLASS IINalbuphine HCl Injection, 20 mg/mL Multiple-dose Fliptop Vial recalledNalbuphine HydrochlorideHospiraSterilityNationwide