JANUARY 2006

WEEK ENDING JANUARY 7

PRODUCT Trypan Blue 0.06% Ophthalmic Solution, packaged one cc syringes, Rx only
CODE Lot numbers: 08182005:43@17; 08012005:63@24; 06282005:91@27; 05252005:36@13 and 05042005:86@17
RECALLING FIRM/MANUFACTURER Custom-Rx Compounding Pharmacy, Richfield, MN
REASON Microbial contamination (Pseudomonas aeruginosa).
VOLUME OF PRODUCT IN COMMERCE 219
DISTRIBUTION Nationwide

WEEK ENDING JANUARY 14

PRODUCT
a) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared from Fission Produced Molybdenum 99, Catalog number N8831L (1.0 curie).
b) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog number N8841L (1.5 curies). 
c) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog number N8851L , 2L (2.0 curies). 
d) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog number N8861L, 2L (2.5 curies).
e) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog number N8871L, 2L (3.0 curies). 
f) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared from Fission Produced Molybdenum 99, Catalog number N8881L, 2L (3.5 curies). 
g) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared from Fission Produced Molybdenum 99, Catalog numbers N8891L, 2L and N8891T, 2T (5.0 curies).
h) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog numbers N8901L, 2L, and N8901T, 2T (6.0 curies),
i) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog numbers N8911L, 2L, and N8911T, 2T (7.5 curies),
j) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog number N8921D, 2D (11.0 curie).
k) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared from Fission Produced Molybdenum 99, Catalog number N8931D, 2D (14.0 curie), 
l) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog number N8941D, 2D (16.0 curie). 
m) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99, Catalog number N8951D, 2D (19.0 curie). 
CODE
a) Lot 5176, Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot 5180, Exp. 11/25/05; Lot 5182, Exp. 11/28/05;
b) Lot 5176, Exp. 11/18/05; Lot 5180, Exp. 11/25/05;
c) Lot 5176, Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot 5179, Exp. 11/23/05; Lot 5180, 

Exp 11/25/05; Lot 5182, Exp. 11/28/05;
d) Lot 5176, Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot 5179, Exp. 11/23/05; Lot 5180,

Exp. 11/25/05; Lot 5182, Exp. 11/28/05;
e) Lot 5176, Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot 5179, Exp. 11/23/05; Lot 5180, 

Exp. 11/25/05; Lot 5182, Exp. 11/28/05;
f) Lot 5176, Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot 5179, Exp. 11/23/05; Lot 5180, 

Exp.11/25/05; Lot 5182, Exp. 11/28/05;
g) Lot 5176, Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot 5180, Exp. 11/25/05; Lot 5182, 

Exp. 11/28/05;
h) Lot 5176, Exp. 11/18/05; Lot 5179, Exp. 11/23/05; Lot 5180, Exp. 11/25/05;
i) Lot 5176, Exp. 11/18/05; Lot 5177, Exp. 11/20/05; Lot 5178, Exp. 11/21/05; Lot 5179, 

Exp 11/23/05; Lot 5180, Exp. 11/25/05; Lot 5181, Exp. 11/27/05; Lot 5182, Exp. 11/28/05;
j) Lot 5176, Exp. 11/18/05; Lot 5177, Exp. 11/20/05; Lot 5178, Exp. 11/21/05; Lot 5179,

Exp. 11/23/05; Lot 5180, Exp. 11/25/05; Lot 5181, Exp. 11/27/05; Lot 5182, Exp. 11/28/05;
k) Lot 5176, Exp. 11/18/05; Lot 5177, Exp. 11/20/05; Lot 5178, Exp. 11/21/05; Lot 5179, 

Exp. 11/23/05; Lot 5180, Exp. 11/25/05; Lot 5181, Exp. 11/27/05; Lot 5182, Exp. 11/28/05;
l) Lot 5176, Exp. 11/18/05; Lot 5177, Exp. 11/20/05; Lot 5178, Exp. 11/21/05; Lot 5179, 

Exp 11/23/05; Lot 5180, Exp. 11/25/05; Lot 5181, Exp. 11/27/05; Lot 5182, Exp. 11/28/05;
m) Lot 5176, Exp. 11/18/05; Lot 5177, Exp. 11/20/05; Lot 5178, Exp. 11/21/05; Lot 5179, 

Exp. 11/23/05; Lot 5180, Exp. 11/25/05; Lot 5181, Exp. 11/27/05; Lot 5182, Exp. 11/28/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt Inc, Berkeley, MO
Manufacturer: Mallinckrodt Inc, Maryland Heights, MO. 
REASON Lack of assurance of sterility: Positive unit found in a media fill run.
VOLUME OF PRODUCT IN COMMERCE 1,646 generators
DISTRIBUTION Nationwide and Internationally

PRODUCT Children’s Motrin Bubblegum Suspension 4 oz bottle, Ibuprofen 100 mg/5ml, OTC, NDC 50580-604-04
CODE Lot number HHM187 exp 8/06
RECALLING FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Presence of particulate matter: product intended for destruction due to white fiber material found on packaging transfer screen was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Simply Sleep Mini-Caplets, (Diphenhydramine HCl) 25mg, 100 mini-caplets per bottle, NDC 50580-843-10
CODE Lot number JFM058 exp 5/06
RECALLING FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Presence of particulate matter: product intended for destruction due to white fiber material found on packaging transfer screen was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Tylenol Sinus Nighttime Caplets, Each caplet contains Acetaminophen 500 mg, Doxylamine succinate 6.25 mg, Pseudoephedrine HCl 30 mg, 12 count blister card packages, 
CODE Lot number JMM087 exp 7/06
RECALLING FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Mispacked; product intended for destruction due to foreign object (ball bearing) found in blister card was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Children’s Tylenol Soft-Chews, (Acetaminophen), 80 mg, 30 tablet bottle, Fruit Flavor, NDC 50580-105-32
CODE Lot number HPM102 exp 8/05
RECALLING FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Label error on declared strength; quantity for other ingredient phenylalanine is listed as 3 mg instead of as 6mg (product intended for destruction was possibly diverted to retail stores).
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide

PRODUCT
a) Children’s Tylenol Oral Suspension, (Acetaminophen), 160 mg/5mL (teaspoon), 4 Fl oz (120mL), bottles, Bubblegum Yum Flavor, NDC 50580-407-04
b) Children’s Tylenol Oral Suspension, (Acetaminophen), 160 mg/5mL (teaspoon), 4 Fl oz (120mL), bottles, Cherry Blast Flavor, NDC 50580-123-04
CODE
a) Lot numbers: JLM121 exp 9/06, and JLM122 exp 9/06;
b) JLM123 exp 9/06
RECALLING FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Presence of foreign substance; pieces of wire tie found, product intended for destruction was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide

PRODUCT
a) Prochlorperazine Edisylate Injection USP 10 mg/2 mL (5 mg/ml) in 2 ml vials. The product is shipped in
shippers that contain 40 cartons and cartons contain 25 vials, Rx only, NDC 0703-7171-04,
b) Prochlorperazine Edisylate Injection USP 5 mg/ml in 10 ml vials. The product is shipped 1 vial per carton, Rx only, NDC 0703-7175-01,
CODE
a) Lot numbers: 03P138, 04A118, 04A125, 04D101, 04D102, 04D111, and 04D129;
b) Lot numbers: 03P115, 04B128, and 04D108
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Sellersville, PA
Manufacturer: Sicor Pharmaceuticals, Inc, Irvine, CA,
REASON Presence of particulate matter.
VOLUME OF PRODUCT IN COMMERCE 733,972 vials
DISTRIBUTION Nationwide

PRODUCT Children’s Tylenol Flu Suspension 4 oz bottle. Acetaminophen (APAP) 160 mg, chlorpheniramine maleate (CPM) 1 mg, dextromethorphan HBr (DXM) 7.5 mg, pseudoephedrine HCl (PSE) 15 mg per 5 ml suspension, OTC,
CODE Lot number JAM149 exp. 01/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Presence of particulate matter: Product intended for destruction due to a small piece of black foreign material observed on the packaging screen was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Children's Tylenol Plus Flu Suspension Bubblegum Flavor 4 oz. Acetaminophen 160 mg per 5 ml, chlorpheniramine maleate 1 mg per 5 ml, dextromethorphan HBr 7.5 mg per 5 ml, and pseudophedrine HCl 15 mg per 5 ml, OTC, NDC 50580-202-04
CODE Lot number JAM217 exp 2/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA.
REASON Presence of particulate matter: product intended for destruction due to wood found on mesh screen was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Tylenol Arthritis Extended Relief Caplets 100 count bottles. Each caplet contains acetaminophen 650 mg, OTC, NDC 50580-112-10
CODE Lot number HAM149 exp 1/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Presence of particulate matter: product intended for destruction due to the possibility of broken metal pieces from the compression punches being compressed in the caplets was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Tylenol Arthritis Extended Relief Caplets 100 count bottles. Each caplet contains acetaminophen 650 mg, OTC
CODE Lot number HAM086 exp 12/05
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Presence of particulate matter: product intended for destruction due to the possibility of broken metal pieces from the compression punches being compressed in the caplets was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Temazepam, USP, 15 mg. capsules, Item # 0067687. Rx. NDC 49999-045-15
CODE Lot 08406; Exp. 07/31/08.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lake Erie Medical & Surgical, Temperance, MI
Manufacturer: Lake Erie Medical & Surgical, Toledo, OH.
REASON Mislabeling: The product is labeled as 15 mg capsules, but the package actually contains 30 mg capsules.
VOLUME OF PRODUCT IN COMMERCE 6 bottles
DISTRIBUTION FL

PRODUCT Infant’s Tylenol Concentrated Drops Cherry Flavor 1/2 oz. Acetaminophen 80 mg/0.8 ml, OTC
CODE Lot number JMM075 exp 10/06
RECALLING FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Presence of particulate matter: Product intended for destruction due lint free cloth found in mixer was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Mylanta Gelcaps, Each gelcap contains: Calcium carbonate 550 mg and Magnesium hydroxide 125 mg, 50 count Solid Gelcaps bottles, NDC 16837-850-50
CODE Lot number JEM115 exp 4/06
RECALLING FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA 
REASON Defective container; missing foil inner seal, product intended for destruction was possibly diverted to retail market.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide

PRODUCT Infants Tylenol Concentrated Drops Plus Cold, Each 0.8mL contains Acetaminophen 80 mg and Pseudoephedrine HC1 7.5mg, ˝ Fl oz (15mL) bottles, NDC 50580-503-15
CODE Lot HJM140 exp 9/05
RECALLING FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Failed pH specification, product intended for destruction was possibly diverted to retail market.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide

PRODUCT Tylenol Allergy Sinus Day Time Gelcaps, Each gelcap contains Acetaminophen 500 mg, Chlorpheniramine maleate 2 mg, and Pseudoephedrine HC1 30 mg, Maximum Strength, 48 count blister pack
CODE Lot HFM048 exp 6/06
RECALLING FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Defective packaging; damage blister card inspection, product intended for destruction was possibly diverted to retail market.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide

PRODUCT Children’s Motrin Oral Suspension, (Ibuprofen), 100 mg/5 ml (teaspoon), 4 Fl oz (120mL) bottles, Original Berry Flavor, NDC 50580-601-04
CODE Lot HCM001 exp 1/06
RECALLING FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Subpotent (product intended for destruction was possibly diverted to retail stores).
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide

PRODUCT Tylenol Allergy Sinus gelcap. Each caplet contains acetaminophen 500 mg, chlorpheniramine maleate 2 mg, and pseudoephedrine HCl 30 mg, OTC
CODE Lot number JMM180 exp 7/06
RECALLING FIRM/MANUFACTURER McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA
REASON Defective container: product intended for destruction due a tear in the pouch was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT
a) Fougera TRIAMCINOLONE ACETONIDE LOTION USP, 0.1%, 60 mL, NDC 0168-0337-60, FOR DERMATOLOGIC USE NOT FOR OPHTHALMIC USE, Rx only,
b) Fougera TRIAMCINOLONE ACETONIDE LOTION USP, 0.025%, 60 mL, NDC 0168-0336-60, FOR DERMATOLOGIC USE NOT FOR OPHTHALMIC USE, Rx only,
c) Fougera FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%, 60 mL, NDC 0168-0059-60, FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE, Rx only,
d) Fougera CLOBETASOL PROPIONATE TOPICAL SOLUTION USP, 0.05%, 50 mL, NDC 0168-0269-50, FOR USE ON THE SCALP FOR DERMATOLOGIC USE ONLY NOT FOR
OPHTHALMIC USE, Rx only,
e) Fougera BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone), 60 mL, NDC 0168-0041-60, FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE, Rx only
f) Fougera BETAMETHASONE DIPROPIONATE LOTION USP, 0.05% (Potency expressed
as betamethasone), 60 mL, NDC 0168-0057-60, FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE, Rx only
CODE
a) Lot T431, exp. 8/07;
b) Lot S999, exp. 8/07;
c) Lot T600, exp. 4/07;
d) Lot T610, exp. 3/07;
Lot T611, exp. 3/07;
e) Lot T480, exp. 9/08; Lot T481, exp. 9/08;
f) Lot T469, exp. 9/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Altana Inc., Melville, NY,
Manufacturer: Altana Inc., Hicksville, NY.
REASON Defective Dropper: The dropper plug does not meet specification in that the container/closure component cannot ensure an adequate opening for dispensing the drug product.
VOLUME OF PRODUCT IN COMMERCE 66,692 units
DISTRIBUTION Nationwide

WEEK ENDING JANUARY 21

PRODUCT
a) Cardioplegia infusion solutions including: Cold Cardioplegia, Warm Cardioplegia, Blood Cardioplegia 1, Blood Cardioplegia 2, Cardioplegia Base 1, Cardioplegia Base 2, Cardioplegia Base, Cardioplegia Reperfusion, Cardioplegia High Potassium, Cardioplegia Low Potassium, Cardioplegia #1, Cardioplegia #2 Cardioplegia #3; Maintenance Cardioplegia, Enriched Cardioplegia, Cardioplegia Base Enriched. Products are manufactured to order and packaged in clear, plastic infusion bags in various volumes, and additionally labeled with component formula and the specified consignee.
b) Oxytocin Infusion Bags, packaged as Oxytocin 10 units, Oxytocin 20 units, Oxytocin 30 units, Oxytocin D5 1/2 NS, Oxytocin in Lactated Ringers. Products are manufactured to order and packaged in clear, plastic infusion bags in various volumes, and additionally labeled with component formula and the specified consignee
c) Magnesium-containing injectable products including: Magnesium 1 GM, Magnesium 2 GM, Magnesium Sulfate 2 GM, Magnesium 4 GM, Hydration-Magnesium in D5W, Magnesium Infusion, Magnesium in Lactated Ringers. Products are manufactured to order and packaged in clear, plastic infusion bags in various volumes, and additionally labeled with component formula and the specified consignee. 
d) Dialysate solutions including: Citrate Dialysate, Heparin Dialysate, Pediatric Dialysate, Hydration
Dialysate #1, Hydration Dialysate #2, CRRT Dialysate, CVVHD (Dialysate) 300, CVVHD (Dialysate) 342, CVVHD Pediatric Formula (Normocarb), CVVHD Formalin #1, CVVHD Formalin #2,
CVVHD Formalin #3, CVVHD Non-Standard, CVVHD D5W, CVVHD 1/2 NS, CVVHD NS.
Products are manufactured to order and packaged in clear, plastic infusion bags in various volumes
and additionally labeled with component formula and the specified consignee. 
e) Antibiotic Irrigation, packaged in 1 Liter clear plastic bags and bottles. Products are manufactured
to order and additionally labeled with component formula and the specified consignee.
f) Bupivicaine 0.25 % and 0.5% Infusion Solutions, also sold as Pain Bags (Bupivicaine 0.25 %). Products are manufactured to order and packaged in clear, plastic infusion bags in various volumes, and additionally
labeled with component formula and the specified consignee.
g) Diltiazem "piggyback" Infusion bags, containing Diltiazem 5mg/ml injection. Products are manufactured to order and additionally labeled with component formula and the specified consignee. 
h) Norepinephrine Bitartrate (piggyback) Infusion Bags, 1 mg/ml. Products are manufactured to order and additionally labeled with component formula and the specified consignee. 
i) Promethazine, manufactured as 25 mg/ml and 50mg/ml vials. Products are manufactured to order and labeled **FOR IM/IV USE ONLY** and additionally labeled with component formula and the specified consignee.
CODE
a) Expiration Date 9/1/05 to 10/15/05;
b) Expiration Date codes between 8/31/05 and 10/16/05;
c) Expiration date codes between 8/31/05 and 10/16/05;
d) Expiration date codes are between 8/21/05 and 10/16/05;
e) Expiration date codes between 8/31/05 and 10/16/05;
f) Expiration date codes between 8/31/05 and 10/16/05;
g) Expiration date codes between 8/31/05 and 10/16/05;
h) Expiration date codes between 8/15/05 and 9/30/05;
i) Expiration date codes between 8/15/05 and 9/30/05.
RECALLING FIRM/MANUFACTURER Central Admixture Pharmacy Services, Inc., Lanham, MD, REASON Bacterial contamination.
VOLUME OF PRODUCT IN COMMERCE 33,682 units
DISTRIBUTION MD, VA, DE and D.C.

PRODUCT
a) Hydrocodone Bitartrate/APAP, 5/500 mg, 15-unit dose packages, NDC #0406035701
b) Hydrocodone Bitartrate/APAP, 10/650 mg, 15-unit dose packages, NDC #0406036101
CODE
a) Lot # 0357J50485, Exp. Date 12/05/06;
b) Lot # 0361J52296, Exp. Date 12/05/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Murfreesboro Pharmaceutical Nursing Supply, Murfreesboro, TN
Manufacturer: Tyco Healthcare Mallinckrodt, Inc., Hobart, NY. 
REASON Mispackaging: Two unit dose packaged drugs were placed into incorrectly labeled boxes.
VOLUME OF PRODUCT IN COMMERCE 598 units
DISTRIBUTION TN

WEEK ENDING JANUARY 28

PRODUCT Adrenalin Chloride Solution, Epinephrine Nasal Solution, USP, l mg per mL, 30mL, Vasoconstrictor, For Topical Application 1:1000, Rx only, NDC 61570-300-31
CODE Lot numbers: 01184M, exp 01/06; 009N4M, exp 03/06; 02325M, exp 08/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN
Manufacturer: Parkedale Pharmaceuticals, Inc., Rochester, MI. 
REASON Split cap thread defects which may lead to a lack of sterility assurance.
VOLUME OF PRODUCT IN COMMERCE 34,389 units
DISTRIBUTION Nationwide

PRODUCT Children's Motrin Dye Free 4 oz bottles Berry Flavor
CODE Lot number FPM009 exp 11/05
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON Product intended for destruction due to foreign organic material/black speck was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Citrucel FiberShake Chocolate .38 oz Packets which are distributed individually as well as in a 5 count starter kits. Methylcellulose (a non-allergenic fiber) 2g...Bulk-forming laxative, Uses***, Warnings***, Directions***, Inactive ingredients***
CODE All lots: Case lots with have an A or N() after the lot number: Lot -- Exp. Date: 05A075 -- MAR-07; 05A076 -- MAR-07; 05B212 -- APR-07; 05F002 -- JUL-07; 05B210 -- APR-07; 05B211 -- APR-07; 05D056 -- MAY-07; 05A049 -- MAR-07; 05F001 -- JUL-07; 05A045 -- FEB-07; 05A046 -- MAR-07; 05A048 -- MAR-07; 05C162 -- MAY-07; 05C164 -- MAY-07; 05F003 -- JUL-07; 05C160 -- APR-07; 05C161 -- APR-07; 05C163 -- MAY-07; 05D057 -- MAY-07
RECALLING FIRM/MANUFACTURER
Recalling Firm: GlaxoSmithKline, Parsippany, NJ
Manufacturer: JB Laboratories, Inc., Holland, MI. 
REASON During stability testing of non-commercial/undistributed lots, packets were found to exceed "Total Coliforms" specification of NMT 10 cfu/g at the 12 month station. All commercial lots are being recalled.
VOLUME OF PRODUCT IN COMMERCE 4,429,192 packets
DISTRIBUTION Nationwide and PR

PRODUCT Infant's Tylenol Concentrated Drops Cherry Flavor 1/2 oz Acetaminophen 80 mg/0.8 ml, OTC,
CODE Lot number JMM075 exp 10/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON Presence of particulate matter: Product intended for destruction due lint free cloth found in mixer was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT
a) Children's Tylenol Plus Cold Nighttime Suspension 4 oz. Grape Flavor,
b) Children's Tylenol Plus Cold Daytime Suspension 4 oz Fruit Flavor,
c) Children's Tylenol Plus Cough and Cold Suspension 4 oz Cherry Flavor,
d) Children's Tylenol Plus Flu Suspension4 oz Bubblegum Flavo
CODE
a) Lot numbers JLM267 exp 9/06, JLM130 exp 9/06, and JLM266 exp 9/06;
b) Lot numbers JLM270 exp 9/06 and JMM177 exp 10/06;
c) Lot numbers JLM200 exp 9/06 and JLM201 exp 9/06;
d) Lot number JLM248 exp 10/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON Product intended for destruction due to tamper evident issue was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Members' Mark brand Arthritis Pain Relief acetaminophen extended-release tablets 650 mg. pain reliever in bottles of 200, OTC; NDC 68196-544-82
CODE Lot 5LE0031; exp. 08/07
RECALLING FIRM/MANUFACTURER Perrigo Company, Allegan, MI
REASON Defective Container: The tamper-evident seal on the mouth of the bottle may not be intact.
VOLUME OF PRODUCT IN COMMERCE 5,472 bottles
DISTRIBUTION Nationwide

PRODUCT Equaline first aid antibiotic ointment --- polymyxin B sulfate --- bacitracin zinc --- first aid antibiotic ointment --- NET WT 1 OZ (28.4 g) --- compare to Polysporin active ingredients --- Active Ingredient (each gram contains) --- Bacitracin zinc 400 units ... Polymyxin B Sulfate 5,000 units
CODE Lots 5F053 (exp. 6/08), 5F055 (exp. 6/08), 5J050 (exp. 10/08)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc, Hawthorne, NY
Manufacturer: Taro Pharmaceuticals, Inc, Brampton, Canada.
REASON Labeling: label error on declared strength of active ingredients bacitracin zinc and polymyxin B sulfate.
VOLUME OF PRODUCT IN COMMERCE 20,916 units
DISTRIBUTION Nationwide

PRODUCT Maximum Strength Tylenol Cold Nighttime Complete Formula 24 Caplets per blister card 

CODE Lot number HJM064 exp 4/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON Mispackaging: Product intended for destruction due to blister cards from HHM227 (same product) were found in the on line rework bin during startup of batch HJM064 was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Altace, Ramipril Capsules, 2.5 mg, 100 capsule bags
CODE Lot 052557B, 052230B, 053676A, 053676B, 055948A, 055023, 055948B, 053803, 052230A, 052557A. All lot codes have an expiration date of 10/31/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH
Manufacturer: Aventis Pharmaceuticals, Inc., Kansas City, MO. 
REASON Labeling: The individual blister cards may contain missing or not clearly printed characters in the expiration dates.
VOLUME OF PRODUCT IN COMMERCE 38 units of 100 capsules each
DISTRIBUTION Nationwide

PRODUCT
a) DDF Doctor's Dermatologic Formula, Organic Sun Protection SPF 30 --- for Sensitive Skin --- Super Antioxidant Complex, Oil & Fragrance-Free --- Meets EU Standards for UVA --- net wt. 4 oz. 113.4 g --- Active ingredients: Titanium Dioxide 2.5% ---Zinc Oxide 4%, UPC 0 60748 00040 3,
b) DDF Doctor's Dermatologic Formula, Moisturizing Photo-Age Protection SPF 30, Delays Skin Aging,
Restores Moisture --- Super Antioxidant Complex, Meets EU Standards For UVA, net. wt. 4 oz. 113.4 g, Active ingredients: Avobenzone 1%, Octinoxate 7.5%, Octisalate 5%, Octocryene 6%, UPC 0 60748 00039 7,
c) DDF Doctor's Dermatologic Formula, Matte Finish, Photo-Age, Protection SPF 30 --- Minimizes Shine, Super Antioxidant Complex, Oil and Fragance-Free, Meets EU Standards for UVA, net wt. 4 oz. 113.4 g, Active ingredients: --- Avobenzone 1% --- Octinoxate 7.5% --- Octisalate 5% --- Octocrylene 6%, UPC 0 60748 00038 0, Recall # D-131-6; d) DDF Doctor's Dermatologic Formula, Protective Eye
Cream SPF 15 --- 0.5 fl. oz. 15 ml --- Active ingredient: Octinoxate 5% --- Octisalate 1% ---
Zinc Oxide 2%
e) DDF Doctor's Dermatologic Formula, Fade Gel 4 ---Hydroquinone 2% --- Proven Lightener, Evens Skin Tone --- Fades Age Spots --- 0.5 fl. oz. 15 ml ---Active Ingredient: Hydroquinone 2%, UPC bar code 0 60748 00032 8
f) DDF Doctor's Dermatologic Formula, Fade Cream, SPF 30 --- Hydroquinone 2%, Minimizes Age Spots, Prevents Recurrence, Enriched Moisturizer, net wt. 1.7 oz. 48 g -- Active Ingredients:
Avobenzone 1% --- Hydroquinone 2% --- Octinoxate 7.5% --- Octisalate 4% --- Octocrylene 5% ---
Oxybenzone 1.5%, UPC 0 60748 00030 4,
g) DDF Doctor's Dermatologic Formula, Glossy Lip Therapy, SPF 15 --- Plumps --- Protects ---
Moisturizes, net wt. 0.25 oz. 7 g --- Active Ingredients: Octinoxate 5% --- Octisalate 3% ---
titanium Dioxide 1%, UPC bar code 0 60748 00041 0,
CODE
All lots & sizes on the market
RECALLING FIRM/MANUFACTURER
Recalling Firm: HDS Cosmetics, Inc., Yonkers, NY
Manufacturer: HDS Cosmetics, Inc., Harrison, NY. 
REASONFirm does not have adequate stability data to support 2 year expiry period for the OTC products.
VOLUME OF PRODUCT IN COMMERCE Approx. 218,189 units
DISTRIBUTION Nationwide

PRODUCT Tylenol Sinus Severe Congestion 24 Caplets per blister card, (Acetaminophen 325 mg), OTC, NDC 50580-442-24
CODE Lot number JLM095, exp. 8/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON CGMP Deviations: Product intended for destruction due to there was a power failure causing an air handling system failure in coating vector pan/exceeded 50 degrees with erratic spray rate was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Children's Motrin Cough Grape Suspension 4 oz , (ibuprofen 100mg & pseudoephedrine HCl 15mg), OTC, NDC 50580-903-04
CODE Lot number JPM182, exp. 10/06
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON CGMP Deviations: Product intended for destruction due to documentation error was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown

PRODUCT Extra Strength Tylenol Caplets 2 count pouches, (Acetaminophen 500mg), OTC
CODE Lot number LAM083, exp. 10/08
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON Mispackaging: Product intended for destruction due to out of specification result because 3 caplets were released into packaging instead of 2 caplets which was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown