Product Recalls in 2012

FDA Drug Class II Terminated

ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15ML LL SYRINGE, NO NEEDLE) 100MCG/ML (10MCG/0.1ML) INJECTA 0.15 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 16 units units

FDA Drug Class II Terminated

CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15 ML, 150 ML, 180 ML, 2 ML, 200 ML, 3 ML, 30 ML, 300 ML, 32 ML, 4 ML, 5 ML, 6 ML, 60 ML, 90 ML; CYANOCOBALAMIN **1

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 86 units units

FDA Drug Class II Terminated

FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 2 units units

FDA Drug Class II Terminated

EDETATE DISODIUM PF IN BSS 3% OPHTHALMIC 10 ML; EDETATE DISODIUM SOLUTION IN ARTIFICIAL TEARS 0.05% OPHTHALMIC 10 ML (2 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 2 units units

FDA Drug Class II Terminated

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.

May 25, 2012 Mallinckrodt Inc. 44,330 bottles units

FDA Drug Class II Terminated

CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML CEFTAZIDIME, LYOPHILIZED, OPHTHALMIC KIT 2.25% KIT 1 KIT

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 197 units units

FDA Drug Class II Terminated

DROPTAINER STERILE PLASTIC (2 X 7ML) 10 BOTTLE 4 PK (2 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 2 units units

FDA Drug Class II Terminated

HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1500MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 7 units units

FDA Drug Class II Terminated

AMINOPHYLLINE 20ML, SDV** 500MG (25MG/ML) INJECTABLE 20 ML (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 1 unit units

FDA Drug Class II Terminated

HYDROXOCOBALAMIN**(VIT B-12) 1000MCG/ML INJECTABLE 30 ML Injectable (4 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 7 units units

FDA Drug Class II Terminated

ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM; ACYCLOVIR OPHTHALMIC 3% SOLUTION 5 ML (2 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 3 units units

FDA Drug Class II Terminated

HYALURONIDASE / LIDOCAINE 7.1U/9.5MG/ML INJECTABLE 105 ML, 210 ML (6 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 17 units units

FDA Drug Class II Terminated

HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 120MG/1.8MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 80MG/1.2MCG/ML INTRATHECAL 10 ML (3 DIFF

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 7 units units

FDA Drug Class II Terminated

BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 22MG/30MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/20MG/ML INTRATHECAL 40 ML; BUPIVAC

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 15 units units

FDA Drug Class II Terminated

CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) 1GM INJECTABLE 10 VIAL (2 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 2 units units

FDA Drug Class II Terminated

CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 0.2% OPHTHALMIC 10 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 1% OPHTHALMIC 10 ML; CYCLOSPORINE (

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 40 units units

FDA Drug Class II Terminated

DEXAMETHASONE/BACTERIOSTATIC WATER IONTOPHORESIS 0.5MG/5ML(0.1MG/ML) INJECTABL 30 ML (1 PRODUCT) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 1 unit units

FDA Drug Class II Terminated

FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML; FORMIX 100MCG / 30MG / 2MG INJECTABLE 10 ML (4 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 12 units units

FDA Drug Class II Terminated

BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECAL 40 ML; BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 600MCG/ML INTRATHECAL 40 ML; BACLOFEN, P.F. 1,000MCG/ML (1MG/ML) IN

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 21 units units

FDA Drug Class II Terminated

DMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE 10 ML, 5 ML (4 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 6 units units

FDA Drug Class II Terminated

HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML, 525 ML, 630 ML; HYALURONIDASE/LIDOCAINE/EPI/BUPIVICAINE INJECTABLE 32 ML, 64 ML (5 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 9 units units

FDA Drug Class II Terminated

BUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 ML (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 1 unit units

FDA Drug Class II Terminated

AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML; AMIKACIN SULFATE**** 4ML SDV 250MG/ML INJECTABLE 40 ML; AMIKACIN SULFATE, LYOPHILIZED 4MG VIAL INJECTABLE 1 KIT,1 VIAL, 2 KIT, 2 KITS, 2 VIAL, 4 KIT, 4 V

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 42 units units

FDA Drug Class II Terminated

DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LIDOCAINE 0.5%/3% INJECTABLE 30 MLS; DEXAMETHASONE ACETATE (LA) 8MG/ML INJECTABLE 100 ML; DEXAMETHASONE IONTOPHORESIS, STER

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 73 units units

FDA Drug Class II Terminated

BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9MG / 0.25MG INJECTABLE 10 ML, 5 ML; BIMIX 15MG / 1MG INJECTABLE 10 ML; BIMIX 18MG / 0.5MG INJECTABLE 10 ML, 5

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 448 units units

FDA Drug Class II Terminated

DMSO/HEPARIN/METHYLPREDNISOLONE 50%/5000U/40MG/50ML SOLUTION 300 MLS (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 2 units units

FDA Drug Class II Terminated

BORON 2MG/ML INJECTABLE 40 ML (2 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 2 units units

FDA Drug Class II Terminated

FOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 2 units units

FDA Drug Class II Terminated

HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIUM*** (25X5ML) 100U/ML INJECTABLE 125 MLS; HEPARIN SODIUM (25X30ML)** 1000U/ML(1MU/ML) INJECTABLE 120 ML, 60 ML, 90 ML; HEPA

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 12 units units

FDA Drug Class II Terminated

HYALURONIDASE/METHYLPREDNISOLONE ACETATE, P.F. 37.5U/20MG/ML INJECTABLE 20 ML (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 4 units units

FDA Drug Class II Terminated

ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 10 units units

FDA Drug Class II Terminated

CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML (10%) INJECTABLE 200 ML, 240 ML, 500 ML; CALCIUM EDTA 150MG/ML INJECTABLE 1000 ML, 800 ML, 900 ML; CALCIUM EDTA 300MG/ML INJECTABLE 400 ML, 500 ML; CALCIUM GL

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 21 units units

FDA Drug Class II Terminated

EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 100 ML, 2400 ML, 500 ML; EDTA CALCIUM DISODIUM SOLUTION 2% OPHTHALMIC 5

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 28 units units

FDA Drug Class II Terminated

DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE 10 ML, 100 ML, 108 ML, 120 MLS, 25 ML, 32 ML, 60 ML, 90 ML, 90 MLS; DIPHENHYDRAMINE, SDV, 25X1ML** 50MG/ML INJECTABLE 25 M

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 26 units units

FDA Drug Class II Terminated

DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 9 units units

FDA Drug Class II Terminated

CLINDAMYCIN OPHTHALMIC (PF) 20MG/ML (2MG/0.1ML) SOLUTION 2 ML; CLINDAMYCIN PHOSPHATE OPHTHALMIC, INTRAVITREAL (P.F.) 1MG/0.1ML INJECTABLE 0.2 ML; CLINDAMYCIN PHOSPHATE SDPF- (0.1ML SYRINGE,30G,1/2")

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 5 units units

FDA Drug Class II Terminated

CYCLOPENT/LIDOCAINE/PHENYLEPHRINE/TROPICAMIDE 0.5%/0.5%/0.625%/0.25% OPHTHALMIC 20 ML (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 1 unit units

NHTSA Ongoing

E/H BRAKE ACTUATOR

May 25, 2012 BELMONT MACHINE CO. 1 units

FDA Drug Class II Terminated

ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML, 20 ML, 40 ML, 5 ML, 60 ML; ETHYL ALCOHOL 20% INJECTABLE 5 ML; ETHYL ALCOHOL 5% INJECTABLE 180 ML, 30 ML; ETHYL ALCOHOL

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 17 units units

FDA Drug Class II Terminated

ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML; ALPROSTADIL 20MCG/ML INJECTABLE 10 ML, 10 MLS, 20 ML, 3 ML, 30 ML, 4 ML, 40 ML, 5 ML, 6

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 529 units units

FDA Drug Class II Terminated

AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16") 40MG/ML INJECTABLE 0.35 ML, 0.95 ML, 1.25 ML (3 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 4 units units

FDA Drug Class II Terminated

GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 1 unit units

FDA Drug Class II Terminated

DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 2 ML, 20 ML, 300 ML; DIAZEPAM 2.5MG/ML INJECTABLE 40 ML; DIAZEPAM 2MG/ML INJECTABLE 100 ML, 50 ML (8 DIFFERENT PRODU

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 13 units units

FDA Drug Class II Terminated

CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 1 unit units

FDA Drug Class II Terminated

ETOMIDATE 0.2% (2MG/ML) INJECTABLE 20 ML (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 1 unit units

FDA Drug Class II Terminated

HYDROGEN PEROXIDE PF 3% INJECTABLE 150 ML, 200 ML, 50 ML, 60 ML (4 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 8 units units

FDA Drug Class II Terminated

EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML; EPIINEPHRINE P.F. (SULFITE-FREE) 1:1,000 (1MG/ML) INJECTABLE 1 ML, 2 ML, 20 ML, 25 M

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 33 units units

FDA Drug Class II Terminated

ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 1 unit units

FDA Drug Class II Terminated

ASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 60 ML; ASCORBIC ACID (CORN SOURCE) 500MG/ML INJECTABLE 100 ML; ASCORBIC ACID, 50ML SDPF, VIAL**

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 19 units units

FDA Drug Class II Terminated

ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML; ATROPINE/EPINEPHRINE/ BSS 0.02MG/0.1MG/ML INJECTABLE 10 ML, 5 ML (8 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 32 units units