CLASS II Drug recall · Reported 7 Nov 2018 · FDA Enforcement Report

Calcium Gluconate 1% Eyewash Oph recalled by Pharm D Solutions

Pharm D Solutions is recalling Calcium Gluconate 1% Eyewash Oph, distributed nationwide in the US. The recall was initiated on 10 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 05072018:27 Discard by: 5/2/2019; 07122018:11 Discard by 7/7/2019
Quantity recalled25 bottles

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-0146-2019
FDA event ID
81002
Recalling firm
Pharm D Solutions, Houston, TX
Classification
Class II
Status
Terminated
Recall initiated
10 Sep 2018
FDA classified
1 Nov 2018
Reported
7 Nov 2018
Type
Voluntary: Firm initiated
Customers notified by
Press Release
Reason category
Sterility

Timeline

10 Sep 2018Recall initiated by company
1 Nov 2018Classified by FDA+52 days
7 Nov 2018Published 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

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

Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0907-10

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lots: 05072018:27 Discard by: 5/2/2019; 07122018:11 Discard by 7/7/2019

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 21 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

78 other products · FDA event 81002

This product is part of a recall event; the main page for the event is Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IITrimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine recalledPharm D SolutionsSterilityNationwide
CLASS IIHCG Lyopholized 1200 IU Injectable, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 recalledPharm D SolutionsSterilityNationwide
CLASS IITri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 recalledPharm D SolutionsSterilityNationwide
CLASS IISermorelin/Ghrp-2 18 mg/6 mg powder, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IIBi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) recalledPharm D SolutionsSterilityNationwide
CLASS IISlenderella Compound Injectable, Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IISermorelin/Ghrp-2 9 mg/9 mg Powder, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix T 101 Alprostadil/Papverine/Phentolamine recalledPharm D SolutionsSterilityNationwide
CLASS IIDexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix 30-1-30 Papavarin 30 mg/Phentolamine recalledPharm D SolutionsSterilityNationwide
CLASS IITestosterone Cypionate/Proprinate 200 mg/10 mg/ Injectable recalledPharm D SolutionsSterilityNationwide
CLASS IIHCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IIBeta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable recalledPharm D SolutionsSterilityNationwide
CLASS IITilarginine Acetate 50 mg/mL, Injectable, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IIProstaglandin E1 40 mcg/mL Injectable, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IITri-Mix XL 150 mg/10 mg/100 mcg a) Injectable recalledPharm D SolutionsSterilityNationwide
CLASS IIEpi-Shugarcaine Kit Solution Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IIHCG Reconstitued 6000 IU Injectable, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IIWater Sterile for Injection IV Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IIProstaglandin E1 150 mcg/mL Injectable, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IISermorelin/Ghrp-2/Theanine/Mannitol 15 mg/6 mg/75 mg/300 mg recalledPharm D SolutionsSterilityNationwide
CLASS IIPhosphate Buffer Solution 0.05 m Aqueous Solution recalledPharm D SolutionsSterilityNationwide
CLASS IIMethylcobalamin 1 mg/mL a) Injectable recalled by Pharm D SolutionsPharm D SolutionsSterilityNationwide
CLASS IIEpinepherine 1 mg/ Injectable Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IIGlutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IIAcetylcysteine Injection 10 mg/ (2 mg/mL) recalled by Pharm D SolutionsPharm D SolutionsSterilityNationwide
CLASS IIAscorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix T-106 30PA-1PH-25A Aqueous Solution Pharm recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix Papaverine/Phentolamine/Alprostadil/Lidocaine recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix ST9D 30PA-2PH-150A Aqueous Solution Pharm recalledPharm D SolutionsSterilityNationwide
CLASS IITestosterone in Grapeseed Oil 200 mg/mL, a), b), c) recalledPharm D SolutionsSterilityNationwide
CLASS IISermorelin/Ghrp-2 9 mg-6 mg Powder, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IIReck Injection, Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IISermorelin/Ghrp-2 6 mg/6 mg Powder, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IIHCG/0.3 gm Mannitol Lyopholized 6000 IU/vial injectable recalledPharm D SolutionsSterilityNationwide
CLASS IIOxytocin in LR/mL IV,Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IICaffeine and Sodium Benzoate Injection 125 mg/125 mg/mL recalledPharm D SolutionsSterilityNationwide
CLASS IILevocarnitine 170 mg/mL Injectable, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IIPhentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm recalledPharm D SolutionsSterilityNationwide
CLASS IIBacteriostatic Water for Injection, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IIHCG/0.3 gm Mannitol Lyopholized, Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix AT-6 Papa 30 mg/Phent 4 mg/Atrop recalled by Pharm D SolutionsPharm D SolutionsSterilityNationwide
CLASS IITrimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable recalledPharm D SolutionsSterilityNationwide
CLASS IIHCG Injectable, Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IIGlutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IIICalcium Gluconate 2.5% a) 25 mg/mL recalled by Pharm D SolutionsPharm D SolutionsSterilityNationwide
CLASS IITrimix T-101 Alprostadil/Phapaverine/Phentolamine recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 recalledPharm D SolutionsSterilityNationwide
CLASS IIPhenol 5% and Glycerin Aqueous Solution Injection recalledPharm D SolutionsSterilityNationwide
CLASS IISermorelin/Ghrp-2/Ghrp-6 Mannitol 9 mg/9 mg/9 mg/300 mg recalledPharm D SolutionsSterilityNationwide
CLASS IIHCG/0.3 gm Mannitol Lyophilized Powder Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IIPyridoxine 100 mg/mL MDV Injectable, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IIProstaglandin E1 80 mcg/mL Injectable, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IIBi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) recalledPharm D SolutionsSterilityNationwide
CLASS IIBi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable recalledPharm D SolutionsSterilityNationwide
CLASS II0.9% Sodium Chloride for Injection, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IISterile Water Aqueous Solution, Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IIGlycerin 72% (Lidocaine/Epi 2 Injectable, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IISermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IIHCG Reconstitued 50,000 IU Injectable, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IIMagnesium 40 gm/ns IV, Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg recalledPharm D SolutionsSterilityNationwide
CLASS IIVigamox Oph. Solution Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IIZinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IICalcium Gluconate 10%, 100 mg/mL Injectable recalledPharm D SolutionsSterilityNationwide
CLASS IIArginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IIQM-4A Quadmix 30 PA-2PH-150A-Atropine 0.4 mg Aqueous recalledPharm D SolutionsSterilityNationwide
CLASS IIHCG Powder, Pharm D Solutions, Houston, Texas recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 recalledPharm D SolutionsSterilityNationwide
CLASS IICalcium Gluconate1% Eyewash 10 mg/mL, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide
CLASS IIBi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL) recalledPharm D SolutionsSterilityNationwide
CLASS IILipo MIC-12 Compound Injectable a) recalled by Pharm D SolutionsPharm D SolutionsSterilityNationwide
CLASS IIPhenol 7% and Glycerin Aqueous Solution Injectable recalledPharm D SolutionsSterilityNationwide
CLASS IITrimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm recalledPharm D SolutionsSterilityNationwide

More recalls from Pharm D Solutions

All 100
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIHuman Chorionic Gonadotropin 10,000 IU vials recalledPharm D SolutionsSterilityNationwide
DrugCLASS IINandrolone Decanoate 200 mg/mL Injectable vials recalledPharm D SolutionsSterilityNationwide
DrugCLASS IISermorelin/Ghrp-2 & 6 (3-3-3 MG) vials recalled by Pharm D SolutionsPharm D SolutionsSterilityNationwide
DrugCLASS IIB-complex (Thiamine 100mg, Riboflavin 2mg recalled by Pharm D SolutionsPharm D SolutionsSterilityNationwide
DrugCLASS IISermorelin/Ghrp-2 9 mg/9 mg vials Pharm D. Solutions recalledPharm D SolutionsSterilityNationwide