CLASS II Drug recall · Reported 22 Jan 2014 · FDA Enforcement Report
Vancomycin HCL 10 mg/mL Ophthalmic Solution recalled
Specialty Medicine Compounding Pharmacy is recalling Vancomycin HCL 10 mg/mL Ophthalmic Solution, distributed in Michigan. The recall was initiated on 19 Oct 2013 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08222013@2
Quantity recalled 50 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-454-2014
FDA event ID 66566
Classification Class II
Status Terminated
Recall initiated 19 Oct 2013
FDA classified 10 Jan 2014
Reported 22 Jan 2014
Type Voluntary: Firm initiated
Customers notified by Press Release
Timeline
19 Oct 2013 Recall initiated by company 10 Jan 2014 Classified by FDA +83 days 22 Jan 2014 Published in enforcement report +12 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: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
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
VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Where it was distributed
Hospitals, clinics, physicians, and patients in the Michigan area only.
Michigan
Questions about this recall
Why was it recalled? Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Which lots are affected? All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08222013@2
Where was it sold? Hospitals, clinics, physicians, and patients in the Michigan area only.
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 66566 This product is part of a recall event; the main page for the event is 0.9% Sodium chloride a) DT-0.9% Sodium chloride* Drug Study recalled .
Reported Class Recall Company Reason Where 22 Jan 2014 CLASS II 0.9% Sodium chloride a) DT-0.9% Sodium chloride* Drug Study recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Combo Eye Gel, HF Combo EYE GEL* (cyclopentolate recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Calcium Chloride* PF 500 mg/mL pref syringe recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Tranexamic Acid* Solution recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Acetylcysteine (PF) 20 % Opthalmic recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Glutathione PF, 60 mg/mL inhalation recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Tropicamide* 1% Ophthalmic Solution recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II DT- Tranexamic Acid* 2 gm/ Drug Study -IV injectable recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Testos Cypionate* IN Oil 100 mg/mL Injectable recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Naltrexone* Mdv 1mg/ML Injectable recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Methocarbamol (Repack) 100 mg/mL Injectable recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Papaverine HCL, 30 mg/mL injectable, also labeled as recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Quad Mix* 0.05 mg/25 mg/2 mg/25 mcg/mL Injectable recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Glycerin-chromated (w/v)* 72% Injectable recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Hydroxocobalamin* 10,000 mcg/mL Injectable recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Phenol, 6%, Injectable recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Methylcobalamin* PF 1000 mcg/mL Pref Syringe recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Sodium tetradecyl SO4, 3% injectable recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Testos Cypionate* IN Olive Oil 200 mg/mL Injectable recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Edetate Disodium* (0.05m) 1.7% Ophth Sol recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Ceftazidime, 22.5 mg/ml (ophthalmic) recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Cyanocobalamin, 1000 mcg/ml; injectable, all sizes recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Triple Mix* 15 mg/1 mg/20 mcg/mL Injectable recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Fluorouracil* PF 50 mg/mL Injectable recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Potassium Phosphate* PF 4.4 Meq/mL Injectable recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Dexamethasone NAPO4* PF 4MG/ML Solution, all sizes recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Aluminum Potassium Sulfate Sterile powder recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Multitrace-4 pediatric injection recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Sodium Thiosulfate PF, 10 % injectable recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Vigamox (moxifloxacin)* IN Bss (0.15 %) 0.75 mg/ Pref Syringe recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Sodium Phosphate* PF 3MMOL/mL Injectable recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Lidocaine/sodium Chl* 0.4 %/18 % Injectable recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Sodium Hydroxide (bac.static) 10% Solution recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Quad Mix* IN Nacl (1.8/0.2/0.02)mg/18 mcg/mL Injectable recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Hydroxocobalamin/Thiamine* 1 mg/100 mg/mL Injectable recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Hydroxyprogest*-17ALPHA -PF 250 mg/mL Injectable recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Cyclopentolate HCL* (for Compounding) 2% Ophthalmic recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Naloxone HCL* 0.4MG/ML Injectable, all sizes recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Proparacaine HCl PF, 0.5% ophthalmic solution recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Epinephrine Pf Sf*; In Syringe) 1:1000 Ophth Sol recalled Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Polidocanol, 3% injectable recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Wb-Tranexamic acid/Placebo, Drug Study recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Hyaluronidase, pf 100U/mL; pf 150 U/mL recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Gatifloxacin 0.5% (ophthalmic) recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Magnesium Sulfate, 1 gm/; 2 gm recalled by Specialty Medicine Specialty Medicine Compounding Pharmacy Sterility MI 22 Jan 2014 CLASS II Flucon/Gent* (fluconazole and gentamicin) 200 mg/480 mg/ Solution recalled Specialty Medicine Compounding Pharmacy Sterility MI
More recalls from Specialty Medicine Compounding Pharmacy All 51
Other Vancomycin recalls All 65