Product Recalls in 2012

FDA Drug Class III 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. 41,100 bottles units

FDA Drug Class II Terminated

DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABLE 100 ML; DMSO FORTIFIED IRRIGATION - W/O HEPARIN SOLUTION 350 ML; DMSO FORTIFIED IRRIGATION 50%/0.01%/44%/1% SOLUTION 100

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 107 units units

FDA Drug Class II Terminated

FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 100 ML; FLUOROURACIL (5-FU) SOLUTION IN ARTIFICIAL TEARS 1% OPHTHALMIC 15 ML; FLUOROURACIL (5-FU) SOLUTION, P.F. 0.001% (10MCG/ML) OPHTHALMIC 20 ML, 30 ML

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 14 units units

FDA Drug Class II Terminated

HYPERTONIC SOLUTION IN PRESERVED WATER 10% INJECTABLE 50 ML (1 PRODUCT)

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

FDA Drug Class II Terminated

HUMULIN-R INSULIN, 10ML VIAL** 100U/ML INJECTABLE 10 MLS (1 PRODUCT)

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

FDA Drug Class II Terminated

BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/100MG/ML INJECTABLE 0.72 ML; BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 3 ML, 4.5 ML; BEVACIZUMAB & DXM

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 2350 units units

FDA Drug Class II Terminated

FUROSEMIDE*** (25X10ML) 10MG/ML INJECTABLE 250 ML; FUROSEMIDE*** (25X4ML) 10MG/ML INJECTABLE 2 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

DEXPANTHENOL 250MG/ML INJECTABLE 100 ML, 120 ML, 360 ML, 450 ML (4 DIFFERENT PRODUCTS)

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

FDA Drug Class II Terminated

BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL IRRIGATION 0.6MG/50ML SOLUTION 1500 ML (2 DIFFERENT UNITS)

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

FDA Drug Class II Terminated

DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 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

DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3 DIFFERENT PRODUCTS)

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

FDA Drug Class II Terminated

DAPIPRAZOLE OPHTHALMIC 0.5% SOLUTION 10 ML; DAPIPRAZOLE, LYOPHILIZED, OPHTHALMIC KIT 0.5% POWDER 1 KIT, 10 KIT, 2 KIT, 3 KIT, 4 KIT, 6 KIT (7 DIFFERENT PRODUCTS)

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

FDA Drug Class II Terminated

ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, 6 PELL, 6 PELLET; ESTRADIOL 50MG PELLETS 1 PELELT, 1 PELLET, 4 PELLET, 6 PELLET; ESTRADIOL CYPIONATE 5MG/ML INJ

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 72 units units

FDA Food Class III Terminated

Bumble Bee Fancy Whole Oysters 12/8 oz can.

May 25, 2012 Bumble Bee International 318735 cases units

FDA Drug Class II Terminated

G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS)

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

FDA Drug Class II Terminated

CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 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

AMPHOTERICIN B OPHTHALMIC (0.5ML, LL SYRINGE) P.F. 10MCG/0.1ML INJECTABLE 1 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML; AMPHOTERICIN B OPHTHALMIC 5MCG/0.1ML INJECTABLE, 0.2 ML, 0.4 ML, 3 ML; AMPHOTERICIN B, LYOPH

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

FDA Drug Class II Terminated

HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE 10 ML, 12 ML, 13 ML, 15 ML, 3 ML, 30 ML, 4 ML, 5 ML, 6 ML, 7 ML, 9 ML (11 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 48 units units

FDA Drug Class II Terminated

BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 20MG/400MCG/20MG/ML INTRATHECAL 20 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

HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 ML, 60 ML (2 DIFFERENT PRODUCTS)

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

FDA Drug Class II Terminated

BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/25MG/ML INTRATHECAL 20 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/50MG/ML INTRATHECAL 18

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

FDA Drug Class II Terminated

HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID SODIUM SALT, P.F. 20MG/ML INJECTABLE 500 ML (3 DIFFERENT PRODUCTS)

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

FDA Drug Class II Terminated

FENTANYL, P.F. 100MCG/ML INJECTABLE 12 ML, 2 ML, 30 ML, 60 ML; FENTANYL, P.F. 50MCG/ML (100MCG/2ML) INJECTABLE 100 ML, 120 ML, 150 ML, 20 ML, 200 ML, 24 ML, 250 ML, 30 ML, 300 ML, 40 ML, 400 ML, 50 M

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 110 units units

FDA Drug Class II Terminated

HYDROMORPHONE P.F. 20MG/ML INTRATHECAL 40 ML; HYDROMORPHONE P.F. 25MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 30MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 50MG/ML INTRATHECAL 40 ML (4 DIFFERENT PR

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

FDA Drug Class II Terminated

BACTERIOSTATIC SODIUM CHLORIDE 10ML VIAL** 0.9% INJECTABLE 10 ML, 10 MLS, 100 ML, 120, 20 MLS, 200 ML, 30 MLS, 40 ML, 50 ML, 50 MLS (10 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 27 units units

FDA Drug Class II Terminated

HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS, 12 MLS, 12.5 ML, 120 MLS, 15 MLS, 16 ML, 16 MLS, 2 MLS, 20 ML, 20 MLS, 24 MLS, 25 ML, 30 ML, 30 MLS, 36 MLS, 4 MLS, 40 MLS

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 326 units units

FDA Drug Class II Terminated

ACETIC ACID, IRRIGATION 3% SOLUTION 500 ML (1 PRODUCT)

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

NHTSA Ongoing

SE-GI VENTED WINDOWS

May 25, 2012 FORETRAVEL, INC. 121 units

FDA Drug Class II Terminated

DOXORUBICIN HCL, LYOPHILIZED 10MG VIAL 2 VIAL; DOXORUBICIN HCL, LYOPHILIZED 50MG VIAL 1 VIAL, 10 VIAL, 5 VIAL (4 DIFFERENT PRODUCTS)

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

FDA Drug Class II Terminated

ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML, 6 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 2.5% SOLUTION 20 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS

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

FDA Drug Class II Terminated

BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 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

CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD) - 45 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-21 DAY 125 UNIT VIALS KIT 1

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 193 units units

FDA Drug Class II Terminated

BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/6MG/ML INTRATHECAL 40 ML; BACLOFEN/HYDROMORPHONE, P.F. 500MCG/50MG/ML INTRATHECAL 40 ML (2 DIFFERE

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

FDA Drug Class II Terminated

BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.25MG/ML OPHTHALMIC 2 ML, 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.5MG/ML OP

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 107 units units

FDA Drug Class II Terminated

FORSKOLIN/PAPAVARINE/PHENTOLAMINE 200MCG/40MG/3MG/ML INJECTABLE 5 ML; FORSKOLIN/PAPAVARINE/PHENTOLAMINE/ALPROSTADIL 100MCG/30MG/1MG/30MCG/ML INJECTABL 10 ML; (2 DIFFERENT PRODUCTS)

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

FDA Drug Class II Terminated

BIEST(80/20) 6.25MG/GM (1.25MG/0.2ML) I-CREAM 6 ML (5 DIFFERENT PRODUCTS)

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

FDA Drug Class II Terminated

BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 7.5MG/1.5MCG/50MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 5MG/500M

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

FDA Drug Class II Terminated

CYCLOPENT/FLURBIPR/PHENYLEPH/PROPARACAINE .25%/0.0075%/0.625%/0.125% OPHTHALMIC 56 ML, 70 ML (2 DIFFERENT PRODUCTS)

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

FDA Drug Class II Terminated

COPPER GLUCONATE 2MG/ML INJECTABLE 30 ML, 60 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

INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75 KIT, 8 KIT; INDOCYANINE GREEN - KIT 1MG INJECTABLE 1 KIT, 10 `KIT, 10 KIT, 100 KIT, 18 VIAL, 2 KIT (51 DIFFER

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 134 units units

FDA Drug Class II Terminated

DICLOFENAC SODIUM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 500MCG/0.1ML INJECTABLE 0.5 ML, 2 ML, 4 ML (3 DIFFERENT PRODUCTS)

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

FDA Drug Class II Terminated

BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML; BACLOFEN/MORPHINE, P.F. 1,500MCG/1.5MG/ML INTRATHECAL 40 ML; BACLOFEN/MORPHINE, P.F. 2,000MCG/25MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODU

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

FDA Drug Class II Terminated

BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHECAL 40 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

BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.5% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL 0.25% INJECTABLE 120 ML,180 ML, 240 ML,

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 79 units units

FDA Drug Class II Terminated

CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 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

GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200MG/ML INJECTABLE 10 ML, 100 ML, 14 ML, 150 ML, 175 ML, 20 ML, 30 ML, 300 ML, 40 ML, 40 MLS, 50 ML, 58 MLS, 70 ML; GLUTAT

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 47 units units

FDA Drug Class II Terminated

GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCTS)

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

FDA Drug Class II Terminated

BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50MCG/2MG/200MCG/50MG/ML INTRATHEC 18 ML; BACLOFEN/CLONIDINE/BUPIV

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

FDA Drug Class II Terminated

GENTAMICIN 40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML; GENTAMICIN / SODIUM BICARBONATE (STERILE) 480MG/LITER SOLUTION 1000 ML; GENTAMICIN /CLINDAMYCIN /POLYMIXIN B/STERILE WATER 0.1%/

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 171 units units

FDA Drug Class I Terminated

V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561; b) 5-count blister pack UPC Code 0972859402; c) 10-count bottle UPC code 0913251017 bottles, Manufactured by The M

May 25, 2012 The Menz Club, LLC 585,000 Capsules units