Specialty Medicine Compounding Pharmacy: 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.

Agency Publication Date: January 10, 2014

Affected Products

Product: Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t10152013@22

Lot Numbers:

t10152013

Product: Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 08132013@1, 08162013@5

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: for both sizes: 08072013@26, 08282013@52, 09112013@31, 09162013@33, 10072013@33, 07242013@47, 08082013@42, 09172013@52, 10162013@35, 07242013@55, 07242013@56, 09122013@36, 09122013@35, 10042013@8, 10042013@9, 07262013@12, 07262013@13, 07262013@14, 07262013@16, 08082013@35, 08082013@41, 08152013@44, 08162013@21, 08292013@53, 08302013@24, 08302013@25, 08302013@35, 09062013@20, 09132013@26, 09132013@12, 09132013@13, 09202013@34, 09202013@35, 09202013@36, 09262013@24, 10092013@36, 10092013@39, 10102013@37, 10112013@34, 10162013@44, 10172013@26, 10172013@27

Product: Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08222013@3

Lot Numbers:

08222013

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10092013@4, 10162013@1

Product: Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t08162013@15

Lot Numbers:

t08162013

Product: CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09262013@1

Lot Numbers:

09262013

Product: DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09112013@1, 09232013@40, t09252013@26

Product: EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t07312013@36, t09182013@5

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10082013@7, 10152013@2, t10102013@1, t10092013@7, t10092013@6, t10142013@60, t10142013@61

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10042013@7

Lot Numbers:

10042013

Product: FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09242013@1

Lot Numbers:

09242013

Product: Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10092013@5, 10162013@2

Product: Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10112013@1

Lot Numbers:

10112013

Product: GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07082013@7, t07112013@1, 08022013@9, t08142013@35, t08222013@15, t10042013@2

Product: Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s:09232013@3, 09102013@5, t09172013@20, 09252013@4, 09252013@7, 10022013@12, 10082013@6, 10142013@58, 10152013@1

Product: HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t08122013@18, t09232013@8

Product: HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09192013@10, 10152013@19

Product: LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t08142013@39, t09052013@40, t09122013@3, t09122013@25

Product: Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07312013@41, 07312013@42, 07312013@43, 07312013@44, 07312013@45, 08012013@1, 08012013@2, 08012013@4, 08012013@6, 08012013@11, 08012013@3, 08012013@5, 08012013@7, 08012013@8, 08012013@9, 08012013@10

Product: METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10042013@1

Lot Numbers:

10042013

Product: 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, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t10072013@4, 10192013@1, 07112013@3, 09052013@6, 09262013@2, 09272013@35, 10012013@26, 08282013@35, t08282013@17, t10092013@30, t10102013@18, t08222013@11, t08292013@21, t08302013@5, t09162013@30, 09162013@46, 09172013@23, t09242013@33, t09302013@25, t10022013@15, t10112013@21, t10162013@4, t08222013@21, t10092013@29

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09242013@10, 07012013@12, 07092013@14, 08132013@22, 08282013@1

Product: NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08292013@10

Lot Numbers:

08292013

Product: NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09262013@3

Lot Numbers:

09262013

Product: Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09242013@8, 09242013@3, 09242013@4, 09242013@6, 09242013@7, 09242013@9, 10012013@1, 10012013@2, 10012013@3, 10012013@4, 10012013@5, 10012013@6, 10032013@6, 10142013@1

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t07312013@20, t09162013@43, t08282013@18, t08292013@11

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 08212013@13, 09112013@2, 09172013@17, 09232013@1, 09242013@13, 10022013@7, 09242013@14, 10022013@9, 10032013@5, 10072013@2

Product: Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 07232013@41

Lot Numbers:

07232013

Product: Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09302013@6

Lot Numbers:

09302013

Product: Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t07312013@28

Lot Numbers:

t07312013

Product: POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10032013@2, 10032013@1

Lot Numbers:

10032013

Product: Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09302013@8

Lot Numbers:

09302013

Product: 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 only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s:t09192013@20, t07312013@12, t07312013@13, t09172013@30, t08142013@10, t08272013@28, t09052013@32, 09162013@40, t09252013@12

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09242013@11, 09242013@12, 10022013@1, 10022013@2, 10082013@1, 10082013@2, 10082013@3, 10092013@1, 10092013@2, 10092013@3, 10152013@15, 09192013@1, 09192013@2, 09192013@3, 09192013@4, 09192013@6, 09192013@7, 09192013@8, 09202013@28, 09202013@29, 10032013@3, 10032013@4, 10152013@3, 10152013@4

Product: Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t08302013@12

Product: Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t10022013@6, 10162013@3, t10172013@10

Product: HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07122013@1, 09162013@6

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08262013@5

Lot Numbers:

08262013

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09182013@42, t09172013@31, t09182013@4

Product: TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08192013@34, t08272013@34, t10012013@28

Lot Numbers:

08192013

Product: TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 08282013@8, 09192013@9, 10142013@2

Product: TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: t10142013@30

Lot Numbers:

t10142013

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t09032013@48, t09252013@37, 09162013@38

Product: VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 08222013@2

Lot Numbers:

08222013

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10012013@23, 10012013@24, 10012013@25, 10012013@9, 10012013@12, 10012013@13, 10012013@15, 10012013@16, 10012013@17, 10012013@19, 10012013@20, 10012013@22

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable lots: 09272013@14, 09272013@4, 09272013@8, 09272013@18, 10142013@3, 10142013@9, 10142013@13, 10142013@15, 10142013@19, 09272013@3, 09272013@7, 09272013@11, 09272013@13, 09272013@17, 10142013@6, 10142013@8, 10142013@12, 10142013@18, 10142013@22; b) Topical lots: 09272013@2, 09272013@6, 09272013@10, 09272013@12, 09272013@16, 10142013@5, 10142013@7, 10142013@11, 10142013@17, 10142013@21, 09272013@5, 09272013@9, 09272013@15, 09272013@19, 10142013@4, 10142013@10, 10142013@14, 10142013@16, 10142013@20

Product: Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09202013@1, 09202013@2, 09202013@3, 09202013@4, 09202013@5, 09202013@6, 09202013@7, 09202013@8, 10102013@7, 10102013@3, 10102013@8

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable 09252013@8, 09302013@2, 10152013@6; b) Topical 09252013@9, 09302013@5, 10152013@8

Product: 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

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable 09252013@10, 09302013@1, 10152013@5, ; b) Topical 09252013@11, 09302013@3, 10152013@7

Product: SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 10152013@20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66566

Status: Resolved

Manufacturer: Specialty Medicine Compounding Pharmacy

Manufactured In: United States

Units Affected: 51 products (20 mL; 160 grams; 2801 doses; 44.44 mL; 38 doses; 180 mL; 5 mL; 70 mL; 30 mL; 157.08 mL; 700 mL; 4.4 mL; 38 doses; 126 mL; 210 mL; 148.075 ml; 70 mL; 53 mL; 65 mL; 19200 mL; 20 mL; 726.45 mL; 186 mL; 120 mL; 100 mL; 5582.6 mL; 35.5 mL; 1351 mL; 11 mL; 6 mL; 10 mL; 600 mL; 6 mL; 86 mL; 9200 mL; 100 mL; 180 mL; 420 mL; 15 mL; 33 mL; 17.5 ml; 3000 mL; 5.5 mL; 44 mL; 50 mL; 204 doses; a) 1900 injectable; b) 1900 mL topical; 8090.8 mL; a) Injectable 800 mL; b) Topical 600 mL; a) Injectable 600 mL; b) Topical 800 mL; 10 mL)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products