Drug recall: Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI…
Class II FDA enforcement event 66566. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Specialty Medicine Compounding Pharmacy started this drug recall on 19 Oct 2013. The firm address in the FDA record is in South Lyon, MI. FDA put the recall in Class II. FDA event 66566 has 51 product records. The first FDA enforcement report date is 22 Jan 2014. The record gives the status Terminated, with the termination date 22 Sep 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Recalling firm
Specialty Medicine Compounding Pharmacy, South Lyon, MI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
51 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-410-2014 | Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 20 mL | Class II | Terminated | 22 Jan 2014 |
| D-411-2014 | Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 160 grams | Class II | Terminated | 22 Jan 2014 |
| D-412-2014 | Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 2801 doses | Class II | Terminated | 22 Jan 2014 |
| D-413-2014 | Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 44.44 mL | Class II | Terminated | 22 Jan 2014 |
| D-414-2014 | Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidocaine jelly 2%), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 38 doses | Class II | Terminated | 22 Jan 2014 |
| D-415-2014 | Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 180 mL | Class II | Terminated | 22 Jan 2014 |
| D-416-2014 | CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 5 mL | Class II | Terminated | 22 Jan 2014 |
| D-417-2014 | DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 70 mL | Class II | Terminated | 22 Jan 2014 |
| D-418-2014 | EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 30 mL | Class II | Terminated | 22 Jan 2014 |
| D-419-2014 | EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 157.08 mL | Class II | Terminated | 22 Jan 2014 |
| D-420-2014 | FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 700 mL | Class II | Terminated | 22 Jan 2014 |
| D-421-2014 | FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 4.4 mL | Class II | Terminated | 22 Jan 2014 |
| D-422-2014 | Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 38 doses | Class II | Terminated | 22 Jan 2014 |
| D-423-2014 | Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 126 mL | Class II | Terminated | 22 Jan 2014 |
| D-424-2014 | GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 210 mL | Class II | Terminated | 22 Jan 2014 |
| D-425-2014 | Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 148.075 ml | Class II | Terminated | 22 Jan 2014 |
| D-426-2014 | HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 70 mL | Class II | Terminated | 22 Jan 2014 |
| D-427-2014 | HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 53 mL | Class II | Terminated | 22 Jan 2014 |
| D-428-2014 | LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 65 mL | Class II | Terminated | 22 Jan 2014 |
| D-429-2014 | Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 19200 mL | Class II | Terminated | 22 Jan 2014 |
| D-430-2014 | METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 20 mL | Class II | Terminated | 22 Jan 2014 |
| D-431-2014 | METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTABLE, METHYLCOBALAMIN* PF 1000 mcg/mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette,… | 726.45 mL | Class II | Terminated | 22 Jan 2014 |
| D-432-2014 | Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate usp, chromium chloride hexahydrate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 186 mL | Class II | Terminated | 22 Jan 2014 |
| D-433-2014 | NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 120 mL | Class II | Terminated | 22 Jan 2014 |
| D-434-2014 | NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 100 mL | Class II | Terminated | 22 Jan 2014 |
| D-435-2014 | Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 5582.6 mL | Class II | Terminated | 22 Jan 2014 |
| D-436-2014 | Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 35.5 mL | Class II | Terminated | 22 Jan 2014 |
| D-437-2014 | Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 1351 mL | Class II | Terminated | 22 Jan 2014 |
| D-438-2014 | Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 11 mL | Class II | Terminated | 22 Jan 2014 |
| D-439-2014 | Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 6 mL | Class II | Terminated | 22 Jan 2014 |
| D-440-2014 | Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 10 mL | Class II | Terminated | 22 Jan 2014 |
| D-441-2014 | POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 600 mL | Class II | Terminated | 22 Jan 2014 |
| D-442-2014 | Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 6 mL | Class II | Terminated | 22 Jan 2014 |
| D-443-2014 | QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, (pavaperine HCl, phentolamine, prostaglandin, atropine sulfate), Rx… | 86 mL | Class II | Terminated | 22 Jan 2014 |
| D-444-2014 | SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 9200 mL | Class II | Terminated | 22 Jan 2014 |
| D-445-2014 | Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 100 mL | Class II | Terminated | 22 Jan 2014 |
| D-446-2014 | Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 180 mL | Class II | Terminated | 22 Jan 2014 |
| D-447-2014 | HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 420 mL | Class II | Terminated | 22 Jan 2014 |
| D-448-2014 | QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 15 mL | Class II | Terminated | 22 Jan 2014 |
| D-449-2014 | TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 33 mL | Class II | Terminated | 22 Jan 2014 |
| D-450-2014 | TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 17.5 ml | Class II | Terminated | 22 Jan 2014 |
| D-451-2014 | TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 3000 mL | Class II | Terminated | 22 Jan 2014 |
| D-452-2014 | TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 5.5 mL | Class II | Terminated | 22 Jan 2014 |
| D-453-2014 | TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 44 mL | Class II | Terminated | 22 Jan 2014 |
| D-454-2014 | VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 50 mL | Class II | Terminated | 22 Jan 2014 |
| D-455-2014 | VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 204 doses | Class II | Terminated | 22 Jan 2014 |
| D-456-2014 | WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | a) 1900 injectable; b) 1900 mL topical | Class II | Terminated | 22 Jan 2014 |
| D-457-2014 | Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 8090.8 mL | Class II | Terminated | 22 Jan 2014 |
| D-458-2014 | 0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | a) Injectable 800 mL; b) Topical 600 mL | Class II | Terminated | 22 Jan 2014 |
| D-459-2014 | DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | a) Injectable 600 mL; b) Topical 800 mL | Class II | Terminated | 22 Jan 2014 |
| D-460-2014 | SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | 10 mL | Class II | Terminated | 22 Jan 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2013
- 370
- Share of these events in Class II
- 56%
- Product records in this event
- 51
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-410-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 66566. https://recallregister.com/fda/ii/66566/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Hospitals, clinics, physicians, and patients in the Michigan area only.
- What quantity of product is in FDA event 66566?
- The event has 51 product records. The first record gives this quantity:
20 mL
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2013 have the same class?
- 56% of the 370 drug events that started in 2013 are in Class II.