CLASS II Drug recall · Reported 15 Jun 2016 · FDA Enforcement Report

MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML recalled

Well Care Compounding Pharmacy is recalling MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, distributed in Nevada. The recall was initiated on 17 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 01182016:46@7, Exp.04/17/2016; Lot #: 02192016 60@29, Exp. 05/19/2016; Lot #: 04082016:83@53; Exp. 07/11/2016; Lot #: 04202016:61@66, Exp.07/19/2016.
Quantity recalled869 Units (Total All Products)

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-0997-2016
FDA event ID
74187
Recalling firm
Well Care Compounding Pharmacy, Las Vegas, NV
Classification
Class II
Status
Terminated
Recall initiated
17 May 2016
FDA classified
9 Jun 2016
Reported
15 Jun 2016
Type
Voluntary: Firm initiated
Customers notified by
Press Release
Reason category
Sterility

Timeline

17 May 2016Recall initiated by company
9 Jun 2016Classified by FDA+23 days
15 Jun 2016Published in enforcement report+6 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 inspection identified GMP violations potentially impacting product quality and 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

MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Where it was distributed

NV

Nevada

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Which lots are affected?

Lot #: 01182016:46@7, Exp.04/17/2016; Lot #: 02192016 60@29, Exp. 05/19/2016; Lot #: 04082016:83@53; Exp. 07/11/2016; Lot #: 04202016:61@66, Exp.07/19/2016.

Where was it sold?

NV

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

50 other products · FDA event 74187

This product is part of a recall event; the main page for the event is Estradiol Cypionate 10 MG/ML recalled by Well Care Compounding Pharmacy.

ReportedClassRecallCompanyReasonWhere
CLASS IIEstradiol Cypionate 10 MG/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIGlutathione 100mg/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIMethylcobalamin 1 MG/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIQuad-mix #3, packaged in 5mL vials, Rx only, Well Care Compounding recalledWell Care Compounding PharmacySterilityNV
CLASS IIQuad-mix #2, packaged in 5mL vial, Rx only, Well Care Compounding recalledWell Care Compounding PharmacySterilityNV
CLASS IIMethylcobalamin 12.5mg/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIItraconazole 0.2%/mupirocin 0.2% Nasal Spray recalledWell Care Compounding PharmacySterilityNV
CLASS IIMyers' Cocktail recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IISuper Tri-mix #4 recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIAlpha Lipoic Acid 25mg/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IITri-mix # 1, packaged in 5mL vials, Rx only, Well Care Compounding recalledWell Care Compounding PharmacySterilityNV
CLASS IIClotrimazole 1%/ Betamethasone Dipropionate 0.05% Otic recalledWell Care Compounding PharmacySterilityNV
CLASS IIMethylcobalamin 5mg/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIVitamin B Complex # recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IISuper Tri-mix #1 recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IITri-mix # 4, packaged in 5 mL vials, Rx only, Well Care Compounding recalledWell Care Compounding PharmacySterilityNV
CLASS IIVitamin B Complex # recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIVancomycin 50mg/ML Ophth Solution recalledWell Care Compounding PharmacySterilityNV
CLASS IIL-glut/l-arg/l-carn recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIGlutathione 200mg/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIM.l.C. 25MG/50MG/25MG/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IITri-mix # 2, packaged in 5mL vials, Rx only, Well Care Compounding recalledWell Care Compounding PharmacySterilityNV
CLASS IIMethylcobalamin/folic Acid recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIM.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML recalledWell Care Compounding PharmacySterilityNV
CLASS IIGentamicin 15 MG/ML Ophthalmic Solution, Sterile Droppers recalledWell Care Compounding PharmacySterilityNV
CLASS II17-0h Progesterone 250mg/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS II1-hcg 2000 IU/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIHcg/methylcobalamin/folic Acid,1000iu/5mg/0.4mg/ML recalledWell Care Compounding PharmacySterilityNV
CLASS IITri-mix # 6, packaged in 5mL vials, Rx only, Well Care Compounding recalledWell Care Compounding PharmacySterilityNV
CLASS IIPhosphatidylcholine/deoxycholic Acid- 5%/4.75% recalledWell Care Compounding PharmacySterilityNV
CLASS II1-hcg 1000 IU/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IILevocarnitine 100mg/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIM.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML recalledWell Care Compounding PharmacySterilityNV
CLASS IIPhenylepherine 0.5%, packaged in 5mL vials, Rx only, Well Care recalledWell Care Compounding PharmacySterilityNV
CLASS IIQuad-mix #1, packaged in 5mL vials, Rx only, Well Care Compounding recalledWell Care Compounding PharmacySterilityNV
CLASS IIItraconazole 0.2%/mupirocin 0.2%/triamcinolone 0.03% Nasal Spray recalledWell Care Compounding PharmacySterilityNV
CLASS IIEstradiol Valerate 10mg/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIQuad-mix #4 (mod) recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIEstradiol Valerate 40mg/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIHydrogen Peroxide recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IITestosterone Cypionate 175mg/ML recalledWell Care Compounding PharmacySterilityNV
CLASS IITri-mix # 3, packaged in 5mL vials, Rx only, Well Care Compounding recalledWell Care Compounding PharmacySterilityNV
CLASS IITestosterone Cypionate 200mg/ML recalledWell Care Compounding PharmacySterilityNV
CLASS IITestosterone Cypionate 150mg/ML recalledWell Care Compounding PharmacySterilityNV
CLASS IITestosterone Cypionate 100mg/ML recalledWell Care Compounding PharmacySterilityNV
CLASS IITestosterone Cypionate 10mg/ML recalledWell Care Compounding PharmacySterilityNV
CLASS IITri-mix # 5, packaged in 5 mL vials, Rx only, Well Care Compounding recalledWell Care Compounding PharmacySterilityNV
CLASS IIEstradiol Valerate 20mg/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
CLASS IIM.i.c. /mb12/b6/dexplan/l-carn, 25mg/50mg/25mg/10mg/10mg/ML recalledWell Care Compounding PharmacySterilityNV
CLASS IIAtropine Sulfate 0.5% Ophthalmic Drops recalledWell Care Compounding PharmacySterilityNV

More recalls from Well Care Compounding Pharmacy

All 51
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIAtropine Sulfate 0.5% Ophthalmic Drops recalledWell Care Compounding PharmacySterilityNV
DrugCLASS IIM.i.c. /mb12/b6/dexplan/l-carn, 25mg/50mg/25mg/10mg/10mg/ML recalledWell Care Compounding PharmacySterilityNV
DrugCLASS IIEstradiol Valerate 20mg/ML recalled by Well Care Compounding PharmacyWell Care Compounding PharmacySterilityNV
DrugCLASS IITri-mix # 5, packaged in 5 mL vials, Rx only, Well Care Compounding recalledWell Care Compounding PharmacySterilityNV
DrugCLASS IITestosterone Cypionate 10mg/ML recalledWell Care Compounding PharmacySterilityNV