CLASS II ONGOING Drug recall · Reported 17 Jul 2013 · FDA Enforcement Report

Iodine 20 mg Injection, compounded by Olympia Pharmacy, Orlando, FL recalled

Lowlite Investments is recalling Iodine 20 mg Injection, compounded by Olympia Pharmacy, Orlando, FL, distributed nationwide in the US. The recall was initiated on 29 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesC51501 Exp 9/30/13

Quantity recalled1

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-743-2013
FDA event ID: 65360
Recalling firm: Lowlite Investments, Orlando, FL
Classification: Class II
Status: Ongoing
Recall initiated: 29 May 2013
FDA classified: 11 Jul 2013
Reported: 17 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

29 May 2013	Recall initiated by company
11 Jul 2013	Classified by FDA	+43 days
17 Jul 2013	Published 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 findings resulted in concerns regarding quality control processes

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

Iodine 20 mg Injection, compounded by Olympia Pharmacy, Orlando, FL

Where it was distributed

Nationwide and PR

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Which lots are affected?

C51501 Exp 9/30/13

Where was it sold?

Nationwide and PR

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 65360

This product is part of a recall event; the main page for the event is Diclazuril 10 mg/ml Injection recalled by Lowlite Investments.

Reported	Class	Recall	Company	Reason	Where
17 Jul 2013	CLASS II	Diclazuril 10 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Ketamine 100 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Metabolase Injection, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Dexpanthenol 250 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Atropine Sulfate 50 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Glutathione 200 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Acepromazine 25 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Oxytocin/ml Injection, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Medroxyprogesterone 150 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Estradiol Cypionate 10 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Detomidine 10 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Diphenhydramine 50 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Phentolamine 20 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Cal-Phos 1000 Injection, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Adenosine-Mono-Phosphate Injection, 200 mg/ml recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Guanabenz 8 mg/ml Injection, compounded by Olympia Pharmacy recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Methylcobalamin 25 mg/ml Inj and 5000 mcg/ml Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Bi mix, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Fluphenazine 25 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Sodium Iodide 20% Injection, compounded by Olympia Pharmacy recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Dextrose 50% Solution, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Phenobarbital 62. 5mg/ml Injection, compounded by Olympia Pharmacy recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Gentamicin 300 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	HCG 125iu/ (550iu/ml), 3500iu and 10,000iu recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Pento-Gluc 200 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Stanozolol (50 mg/ml and 100 mg/ml) Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Guanabenz 20 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Sermorelin/GHRP 3 mg/3 mg vial recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Praziquantel 56.8mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Trimix, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Aminocaproic Acid 250 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Idoxuridine 0.1% Injection, compounded by Olympia Pharmacy recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Enrofloxacin 20 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Gentamicin Sulfate 80 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Vitamin B12 (3000 mcg/ml & 5000 mcg/ml) Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Testosterone Cypionate (100 mg/ml & 200 mg/ml) Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	ITPP 50 mg/ml DMG 100 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Gaba 50 mg/Mag Sulfate 50 mg/Taurine/Theanine 50 mg/ml recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Xylazine 300 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Altrenogest 50 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Cre-O-Pan Injection, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Lipotoxin Injection, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Progesterone 100 mg/ml in Olive Oil Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Metoclopramide 5 mg/ml Injection,compounded by Olympia recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Calcium Gluconate 23%, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Phenylephrine 1 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Yohimbine 10 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Progesterone EO 100 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Phenylbutazone 200 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Neomycin / Polymyxin / Dexamethasone Ophthalmic Drops recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Metabolase Forte Injection, compounded by Olympia Pharmacy recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Vitamin A/D3/E Olive Oil Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Methylprednisolone Acetate 80 mg/ml Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Hippiron 20 mg/ml Injection, compounded by Olympia Pharmacy recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Medetomidine 2 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Tacrolimus (0.02% and 0.03%) drops recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Tripelennamine 20 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Quadmix, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Detomidine w/Xylazine 100 mg/mg Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Pentosan 250 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Papaverine 40 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Methylcobalamin P Creatine 40 mg/ml / Arginine 100 mg/ml recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Aminocaproic Acid 0.5mg/ml Injection,compounded by Olympia recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Deslorelin 15 mg vial, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Caco/Copper recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Gentamicin 0.3% Injection, compounded by Olympia Pharmacy recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	L-ArGiNINE 200 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Furosemide 50 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Sodium Tetradecyl Sulfate (0.125% recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Clenbuterol 0.03mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Aminophylline 2.5% Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	BNP/Dexamethasone Eye Ointment recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Dexamethasone Sodium Phosphate 6 mg/ml Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Beta Alanine 100 mg/ml / l-carnosine 100 mg/ml Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	HACC 270.1 Injection, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Betamethasone Sodium Phosphate 12 mg/ml Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Vitamin B12 Cyanocobalamin 5000 mcg Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Vitamin 15 (HEMO15) Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Naproxen 100 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Betamethasone Phosphate/Acetate 6 mg/ml Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Miconazole 3% Injection, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Disodium EDTA Injection, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Sodium Salicylate 40% Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Gentamicin 80 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Doxapram 20 mg/ml Injection, compounded by Olympia Pharmacy recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Potassium Phosphate Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Chlorpromazine HCL 100 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Meloxicam 5 mg/ml Injection, compounded by Olympia Pharmacy recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Estradiol Cypionate 2 mg/ml Test Cyp 50 mg/ml Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Methylcobalamin 1 mg/ml / Folic Acid 2.5 mg/ml Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Pen-dex-chlor Injection, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Ceftiofur GM vial 50 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Taurine 100 mg/ml Injection, compounded by Olympia Pharmacy recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Polidocanol (0.75%, 1%, 3%, and 10%) Injection recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Amikacin Sulfate 250 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Ketoprofen Solution 10% Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Atipamezole 10 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013	CLASS II	Lisinopril 20 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

More recalls from Lowlite Investments

All 105

Reported	Class	Recall	Company	Reason	Where
17 Jul 2013Drug	CLASS II	Buprenorphine 0.3 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Voriconazole 5% Ophthalmic drop compounded by Olympia recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Vitamin B-Buildup Injection, compounded by Olympia Pharmacy recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Micc (Methionine, Inositol, Choline, Cyanocobalamin recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Lisinopril 20 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide