APRIL 2006

WEEK ENDING APRIL 1

PRODUCT
a) Cytosol Ophthalmics Balanced Salt Solution (Sterile Irrigating Solution) 200mL and 500mL glass bottles, 18mL, 250mL and 500mL plastic bottle, NOT FOR INTRAVENOUS USE, Rx Only, Single
Dose Container Sterile. NDC 23731-8100-5,
b) AKORN Balanced Salt Solution, 500mL glass bottle, NOT FOR INTRAVENOUS USE,
Rx only, Single Dose Container,
CODE All Lots
RECALLING FIRM/MANUFACTURER Cytosol Laboratories, Inc., Braintree, MA
REASON Product not manufactured in accordance with cGMPS as finished product positive for endotoxins resulting in serious injury.
VOLUME OF PRODUCT IN COMMERCE 1,094,523 bottles
DISTRIBUTION Nationwide, Australia, Brazil, Canada, and Germany

PRODUCT Pulmicort Turbuhaler (budesonide inhalation powder), 200 mcg/dose, 200 metered dose inhalers and 200 metered dose professional samples, Rx only, for oral inhalation, NDC: 0186-0915-42
CODE Affected Lots and Expiration Dates: GD2143 10/2006 GI2228 3/2007 GD2144 10/2006 GI2230 3/2007 GD2161 10/2006 GI2241 3/2007 GD2164 10/2006 GI2244 3/2007 GE2170 11/2006 GI2246 3/2007 GE2172 11/2006 GK2247 4/2007 GF2190 12/2006 GK2248 4/2007 GH2196 2//2007 GK2254 4/2007 GH2201 2/2007 GK2255 4/2007 GH2203 2/2007 GK2258 4/2007 GH2207 2/2007 GK2261 4/2007 GH2212 2/2007;
PROFESSIONAL SAMPLES: GD2148 10/2006 GD2150 10/2006 GD2162 10/2006 GH2199 2/2007 GH2211 2/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: AstraZeneca LP, Westborough, MA
Manufacturer: AstraZeneca, Sodertalje, Sweden
REASON The turbuhaler may not deliver proper metered dose: may dispense a super-potent dose.
VOLUME OF PRODUCT IN COMMERCE 417,605 inhalers
DISTRIBUTION Nationwide

PRODUCT Visine A Antihistamine and Redness Relief Eye Drops, Ophthalmic solution, Pheniramine Mealeate (0.3%) and Naphazoline Hydrochloride (0.05%), 0.5 fluid ounce (15mL) x 2 bottles (promotional bonus pack)
CODE Case UPC -- Case Lot No: 1007430089860 2: 01725CD04; 01725CM04; 02325CD04. 1007430089736 0: 01125CN04; 01415CN04; 01815CN04; 01215CN04; 01425CD04; 01915CD04; 01225CD04; 01425CN04; 01915CN04; 01225CN04; 01715CD04; 02014CD04; 01315CD04; 01715CN04; 02125CD04; 01315CN04; 01815CD04. 0007430089748 6: 01425CN04; 01525CN04; 02125CN04; 01525CD04; 01625CN04; 02525CD04; 01525CM04; 02125CD04. 0031254789734 1: 00525CD02; 00825CN02; 01125CD02; 00525CN02; 00925CD02; 01125CN02; 00725CD02; 00925CN02; 01725CN12; 00725CN02; 01025CD02; 03035CD01; 00825CD02; 01025CN02. 0007430089737 0: 01125CN04; 01225CN04; 01425CN04; 01225CD04; 01425CD04; 02125CD04. 1007430089792 6: 00125CD04; 01425CN04; 02015CN04; 00125CN04; 01525CD04; 02515CD04; 00225CD04; 01525CM04; 02515CN04; 00725CD04; 01525CN04; 02525CD04; 00725CN04; 01625CN04; 02615CD04; 00825CD04; 02115CD04; 02615CN04; 00825CM04; 02115CN04; 02715CD04; 00825CN04; 02125CD04; 02715CN04; 00925CD04; 02125CN04; 02815CD04; 00925CM04; 02415CD04; 02815CN04; 00925CN04; 02415CD04A. 0007430008158 8: 00225CN04; 00525CM04; 01025CN04; 00325CD04; 00525CN04; 01125CD04; 00325CN04; 00835CD11; 01125CM04; 00425CD04; 00925CN04; 01725CM04; 00425CN04; 01025CD04; 02225CD04; 00525CD04 01025CM04; 02325CD04. 1007430008157 8: 00225CN04; 00515CD04; 00615CN04; 00323CD04; 00515CN04; 00615CD04; 00325CN04; 00516LLD04; 00616LLD04; 00415CD04; 00516LLD04A; 00616LLM04; 00415CN04; 00516LLM04; 00616LLN04; 00416LLN04; 00516LLN04; 00715CD04; 00416LLN04A; 00525CD04; 00715CN04; 00425CD04; 00525CM04; 00835CD11; 00425CN04; 00525CN04; 00916LLD04; 00916LLN04; 01125CD04; 00916LLD10; 00916LLN10; 01125CM04; 02325CD04; 00925CN04; 01225CD04; 027D5LLN10; 01015CD04; 01215CD04A; 028D4CD04; 01015CN04; 01215CN04; 028D4CN04; 01016LLM04; 01725CM04; 028D5LLD10; 01025CD04; 02225CD04; 028D5LLN10; 01025CM04; 023D4CD04; 029D4CD04; 01025CN04; 023D4CD04A; 029D4CN04; 01115CD04; 023D4CN04; 030D4CD04; 01115CN04; 030D4CN04
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer, Inc., Morris Plains, NJ
Manufacturer: Akorn, Inc., Decatur, IL
REASON Container Leakage: Promotional packager used knives to open boxes containing the plastic bottles of Visine-A in violation of SOP. Bottles were cut and packaged for distribution. Complaints of empty bottles were received.
VOLUME OF PRODUCT IN COMMERCE 532,419 units
DISTRIBUTION Nationwide

PRODUCT
a) Advil Tablets, (Ibuprofen) 200mg, 165 count tablets, Pain Reliever/Fever Reducer
b) ADVIL LIQUI-GELS, (Solubilized Ibuprofen Capsules), 200mg, 135 count bottle, Pain Reliever/Fever Reducer
c) Advil Caplets (Ibuprofen), 200mg, 165 count bottles, Pain Reliever/Fever Reducer
d) Advil Gel Caplets (Ibuprofen) 200mg, 165 count bottles, Pain Reliever/Fever Reducer
CODE
a) A43015, A44820, A47109, A47128, A49043, A49045, A51281, A51282, A51288,
A53439, A53451, A53475, A54750, A58552, A58583, A64046, A64090, A66327, A66336,
A66340, A73274, A73280, A73301, A77169, A77170, A82380, A82397, A82418, A86698,
A86700, A88360, A94538, A94547, and A94548;
b) A20744, A43135, A43136, A75133, A75247, A76963, A80522, A80523, A80525, A80673,
A81563, A83977, A83981, A87708, A87798, A87800, A94557, A94558, A99286, and A99287;
c) A44821, A49032, A51265, A53444, A58547, A59282, A66298, A77177, A8699;
d) A73268, A85252, and A85254
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Rouses Point, NY
Manufacturer: Wyeth Pharmaceuticals, Guayama, PR, 
REASON The immediate container (bottle) label does not have warning statement for non-child resistant packaging -- “THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN”.
VOLUME OF PRODUCT IN COMMERCE 2,826,666 bottles
DISTRIBUTION Nationwide and HI

WEEK ENDING APRIL 8

PRODUCT Minitran (nitroglycerin) Transdermal Delivery System. 0.1 mg/hr. This system is a unit designed to provide continuous controlled release of nitroglycerin through intact skin. NDC 0089-0301-02
CODE Lot no. 050359, expires May 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: 3M Company, St Paul, MN.
Manufacturer: 3 M Company, Northridge, CA,
REASON Subpotent: partial patches will deliver less than the labeled amount of 0.1 mg/hr.
VOLUME OF PRODUCT IN COMMERCE 311,040 patches (30 patches per box)
DISTRIBUTION Nationwide

PRODUCT Oncaspar (Pegaspargase), Lot (1 unit dose per unit package) BLA STN 103411, 750 I.U. per mL, Sterile, NDC 57665-002-02
CODE Lot AF02424, Exp. 8/24/2006
RECALLING FIRM/MANUFACTURER Enzon Pharmaceuticals, Inc., South Plainfield, NJ
REASON Superpotent: At the 18 month stability station, the enzymatic activity is above specification coming in at 907 IU/mL. (Spec. 600-900 IU/mL).
VOLUME OF PRODUCT IN COMMERCE 1,746 vials
DISTRIBUTION Nationwide, Canada, New Zealand, Singapore, and Australia

PRODUCT Hydrocortisone Valerate Cream USP, 0.2%, 15 g tube, Rx only, NDC 51672-1290-1,
CODE Lot 5E040 (exp. Aug 2006)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY
Manufacturer: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada
REASON Sub-Potency: Out of specification (below potency) assay values obtained during stability testing for hydrocortisone valerate cream at 9-month test station. Two tubes were at approx.85% (specification is 90.0% - 110.0%).
VOLUME OF PRODUCT IN COMMERCE 21,984 tubes
DISTRIBUTION Nationwide

WEEK ENDING APRIL 15

PRODUCT Cefazolin for Injection, USP, 1 g/10 mL vials, single use vials, 25 single use vials per carton, Rx only. Distributed under the Watson Laboratories Inc. label: NDC 0591-2365-69 (carton) and NDC 0591-2365-79 (vial), Cefazolin for Injection, USP, 1 gram, For IM or IV Use, Rx only, distributed under the SANDOZ label: NDC 0781-3157-96 (carton) and NDC 0781-3157-70 (vial), Cefazolin for Injection, USP, 1 gram, For IM or IV Use, Rx only,  
CODE Sandoz lots: C4650 (exp. OCT 2007) and C4537 (exp. AUG 2007), NDC 0781-3157-96 (carton) and NDC 0781-3157-70 (vial); Watson lots: C4689 (exp. SEP 2007) and C4665 (exp. AUG 2007), NDC 0591-2365-69 (carton) and NDC 0591-2365-79 (vial)
RECALLING FIRM/MANUFACTURER G. C. Hanford Manufacturing Co., Syracuse, NY
REASON Non Sterility:  Finished product lots lack sterility assurance because certain lots of the bulk API were found to haave microbial contamination.
VOLUME OF PRODUCT IN COMMERCE 379,975 – 1 g/10mL vials
DISTRIBUTION Nationwide

PRODUCT
a) Miracle II, by Tedco, Neutralizer Gel, Nature’s Miracle for the Total Body,
    Sopi’ H20, Biodegradable, 8 oz (232mL), 22 oz, 1 gal, 5 gal, and 15 gal,
b) Miracle II, by Tedco, Neutralizer Gel, Nature’s Miracle for the Total Body,
    Sopi’ H20, Biodegradable, 8 oz (232mL), 7X, 8 oz, 22 oz, and 1 gallon, 
c) Miracle II, by Tedco, Neutralizer, Nature’s Miracle for the Total Body,
    Sopi’ H20, Biodegradable, 22 oz (638mL), 1 gal, 5 gal, and 15 gal, and 55 gal,
d) Miracle II, by Tedco, Neutralizer, Nature’s Miracle for the Total Body,
    Sopi’ H20, Biodegradable, 2X, 22 oz and 1 gal
e) Miracle II, by Tedco, Neutralizer, Nature’s Miracle for the Total Body,
    Sopi’ H20, Biodegradable, 3X, 22 oz and 1 gal
CODE All codes
RECALLING FIRM/MANUFACTURER Tedco, Inc., West Monroe, LA
REASON Microbial contamination
VOLUME OF PRODUCT IN COMMERCE 284,734 units
DISTRIBUTION Nationwide, Canada, Germany, Australia, UK, and Spain

PRODUCT Morphine Sulfate, 1 mg/mL in 0.9% Sodium Chloride, Rx only, Total Dose 100 mg/100mL, 100 mL Medication Cassette Reservoir, NDC 61553-821-48
CODE Lot number 053570081, Service code number 2K8821
RECALLING FIRM/MANUFACTURER PharMEDium Services, LLC, Cleveland, MS.
REASON Mislabeling:  Product labeled as Morphine Sulfate contained Fentanyl Citrate/Bupivacaine HC1.
VOLUME OF PRODUCT IN COMMERCE 120 units
DISTRIBUTION Nationwide

PRODUCT Fentanyl Citrate, 2 mcg/mL and 0.125% Bupivacaine HC1 in 0.9% Sodium Chloride, Rx only, Total Dose 200 mcg/100mL Fentanyl Citrate, 100 mL Medication Cassette Reservoir, NDC 61553-861-48
CODE Lot number 053570083, Service code number 2K8861
RECALLING FIRM/MANUFACTURER PharMEDium Services, LLC, Cleveland, MS
REASON Mislabeling:  Product labeled as Fentanyl Citrate/Bupivacaine contained Morphine.
VOLUME OF PRODUCT IN COMMERCE 120 units
DISTRIBUTION Nationwide

PRODUCT Benylin Pediatric Oral Solution, in each 5mL (dextromethorphan HBr) 7.5mg, supplied in 4 fl oz (118 mL) bottles, Cough Suppressant, Alcohol Free, Sugar Free, Great Grape Flavor, CODE Unit Lot numbers 21934L, Exp. Feb 2006 and 403N4L, Exp. Oct 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Pfizer, Inc., Morris Plains, NY
Manufacturer:  Pfizer, Inc., Lititz, PA
REASON Product exceeds the maximum amount allowed per daily dose, under U.S. Food & Drug Administration regulation for the quanity of FD&C Red Dye No. 33.
VOLUME OF PRODUCT IN COMMERCE 57,412 bottles
DISTRIBUTION Nationwide and PR

WEEK ENDING APRIL 22

PRODUCT
a) SODIUM THIOSULFATE INJECTION, USP, 10%, 100 mg/mL (1g/10 mL), 10 mL SINGLE DOSE VIAL and 5 x 10 mL SINGLE DOSE VIALS, Rx Only, NDC 0517-1019-05
b) SODIUM THIOSULFATE INJECTION, USP, 25%, 250 mg/mL (12.5 g/50 mL), 50 mL SINGLE DOSE VIAL, Rx Only, NDC 0517-5019-01,
CODE
a) Lot 5309 (exp. May 2008);
b) Lot 4769 (exp. December 2007) and 5404 (exp. June 2008)
RECALLING FIRM/MANUFACTURER Luitpold Pharmaceuticals, Inc., Shirley, NY
REASON Failed specification for pH.
VOLUME OF PRODUCT IN COMMERCE 63,564 vials
DISTRIBUTION Nationwide, and Hong Kong

PRODUCT Member’s Mark brand Aspirin 81 mg, Enteric Safety Coated, Adult Low Strength, 500 tablet bottles, NDC 68196-535-90
CODE Lots 5ME0540 and 5ME0956
RECALLING FIRM/MANUFACTURER Perrigo Company, Allegan, MI
REASON Mislabeled; drug identification logo “L535" may not have been completely embossed onto the tablet.
VOLUME OF PRODUCT IN COMMERCE 14,652 bottles
DISTRIBUTION Nationwide

PRODUCT Member’s Mark brand Maximum Strength Allergy Sinus Daytime (acetaminophen 500 mg, chlorpheniramine maleate 2 mg and phenylephrine HC1 5 mg) Caplets, packaged in 100 + 100 =200 Caplet bottles, NDC 68196-223-78,
CODE Lots 5HE0910, 5HE0911, 5HE0912, 5HE0913, 5HE0914, 5HE0915, 5JE0747, 5JE0748, 5KE0261, 5KE0940, 5JE0942, 5KE0944, 5KE0945, 5KE0946, 5LE0569, 5LE0769, 5LE0770, 5KE0085, 5ME0179, 5ME0248, 5ME0689, 6AE0396, 6AE0397, 6AE0422 and 6AE0791
RECALLING FIRM/MANUFACTURER Perrigo Company, Allegan, MI
REASON The tamper evident seal on the carton states 'sealed in blister units for your protection', but the product is actually packaged in bottles.
VOLUME OF PRODUCT IN COMMERCE 364,644 cartons
DISTRIBUTION Nationwide

PRODUCT Focalin XR (dexmethylphenidate HCL), 5 mg, CII, 100 capsules, NDC 0078-0430-05, Rx only
CODE Lot F0003 , Exp. JUL 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals, Corp., Suffern, NY
Manufacturer: Elan Holdings, Inc., Gainesville, GA,.
REASON Superpotent
VOLUME OF PRODUCT IN COMMERCE 14,001 -- 100 count bottles
DISTRIBUTION Nationwide and PR

WEEK ENDING APRIL 29

PRODUCT
a) Tizanidine Hydrochloride Tablets, 4 mg, Rx only, NDC 0093-5160-51,
b) Tizanidine Hydrochloride Tablets, 2 mg, Rx only
CODE
a) Lot # 22765D exp 3/06, 22766D exp 3/06, 22767D exp 3/06, 22609 exp 3/06,
22610 exp 3/06, 22762 exp 4/06, 22763 exp 4/06, 22764 exp 7/06,
23241 exp 7/06, 23242 exp 7/06, 23348 exp 8/06, 23349 exp 8/06,
23739 exp 9/06, 23740 exp 9/06, 23854 exp 11/06, 23963 exp 12/06,
23964 exp 1/07, 24077 exp 2/07, 24369 exp 2/07, 24454 exp 2/07,
24626 exp 4/07, and 24627 exp 4/07;
b) Lot # 22791D exp 4/06, 22792D exp 4/06, 22793D exp 4/06, 22805 exp 4/06,
23745 exp 9/06, 23965 exp 10/06, 23966 exp 1/07, and 24375 exp 3/07
RECALLING FIRM/MANUFACTURER Teva Pharmaceuticals, Sellersville, PA
REASON Dissolution Failure
VOLUME OF PRODUCT IN COMMERCE 515,842 bottles
DISTRIBUTION Nationwide

PRODUCT
a) Analpram HC Cream 2.5% (hydrocortisone acetate 2.5% and
pramoxine HCl 1%) Net Wt. 1 oz tube, Rx only, NDC 0496-0800-04,
b) Analpram HC Cream 2.5% (hydrocortisone acetate 2.5% and
pramoxine HCl 1%) Professional sample, Net Wt. 3 gram tube,
Rx only, NDC 0496-0800-33
c) L.M.X.5 (lidocaine 5%) Anorectal Cream, Net Wt. 15 gram tube,
OTC, NDC 0496-0883-15,
d) Analpram HC Cream 1% (hydrocortisone acetate 1% and
pramoxine HCl 1%) Net Wt. 1 oz tube, Rx only, NDC 0496-0778-04,
CODE
a) Lots 04122A (exp. 07/06), 04123A (exp. 07/06), 04124A (exp. 07/06),
04138A (exp. 08/06), 04139A (exp. 08/06), 05042A (exp. 02/07),
05044A (exp. 02/07), 05058A (exp. 03/07), 05059A (exp. 03/07),
05060A (exp. 03/07), 05068A (exp. 03/07), 05079A (exp. 04/07),
05080A (exp. 04/07), 05081A (exp. 04/07), 05091A (exp. 04/07),
05092A (exp. 04/07), 05093A (exp. 04/07), 05094A (exp. 06/07),
05095A (exp. 06/07), 05096A (exp. 08/07), 05173A (exp. 08/07)
and 05231A (exp. 08/07);
b) Lots 05145A (exp. 05/07), 05079B (exp. 04/07), 05080B (exp. 04/07), and 05081B (exp. 04/07);
c) Lots 04021A (exp. 04/06) and 05085A (exp. 04/08);
d) Lots 04135A (exp. 08/07), 04136A (exp. 08/07), 04186A (exp. 11/07),
04189A (exp. 11/07), 04190A (exp. 11/07), 04191A (exp. 11/07),
04201A (exp. 12/07) and 04202A (exp. 12/07)
RECALLING FIRM/MANUFACTURER Ferndale Laboratories, Inc., Ferndale, MI
REASON Reports of adverse events: The firm redesigned the applicator and, since the design change, patients have reported being injured by the applicator upon use.
VOLUME OF PRODUCT IN COMMERCE 414,259 tubes
DISTRIBUTION Nationwide

PRODUCT Nugest 900 Topical Cream, Progesterone USP, packaged in 2-oz. jars
CODE Lot number: 51311
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nutraceutics, Saint Louis, MO
Manufacturer: GDMI, Inc., Garland, TX
REASON Unapproved New Drug; over the counter cream contains Progesterone, USP.
VOLUME OF PRODUCT IN COMMERCE 3,379 jars
DISTRIBUTION Nationwide

PRODUCT Methylphenidate Hydrochloride Extended-Release Tablets, USP, 20 mg, CII, Rx only, 100 Tablets, NDC 0591-3111-01
CODE Lot L5L1270, Exp. Date 12/31/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Laboratories, Inc., Corona, CA.
Manufacturer: Watson Laboratories, Inc., Carmel, NY
REASON Failed Dissolution Specification; 3-month stability.
VOLUME OF PRODUCT IN COMMERCE 4,993 bottles
DISTRIBUTION Nationwide and PR

Pascal Company, Inc. Initiates Worldwide Recall 

Pascal Company, Inc., located in Bellevue, Washington, is recalling all lots and all flavors of their products, NeutraGard 0.05% Neutral Sodium Fluoride Anticavity Treatment Rinse and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse, all flavors (Mint and Tropical Blast) packaged in clear 16 oz plastic bottles because they may be contaminated with bacteria called Burkholderia cepacia and Pseudomonas aeruginosa.

Approximately 55,000 bottles were distributed worldwide since 2001 to dental wholesalers, who in turn distributed the products to dental offices. These products were not available at any retail outlets or pharmacies.

Consumers and dental offices that have the product should discontinue use of the product and destroy it immediately, or return it to their place of purchase for further processing. 

Consumers with questions regarding the recall may contact Pascal Company, Inc. at 800-426-8051, or go to http://www.pascaldental.com/, and click on the NeutraGard Rinse recall link.