JULY 2006

WEEK ENDING JULY 8

PRODUCT Amantadine HCI, USP, 100 mg, Soft Gelatin Capsules, shipped in bulk cartons of 20,000 capsules each, CAUTION: For Further Manufacturing, Processing or Repackaging Only, Rx ONLY, 
CODE Lot numbers:  25101150, 25030655 and 25101146
RECALLING FIRM/MANUFACTURER Banner Pharmacaps, Inc., High Point, NC
REASON Failed USP Content Uniformity Requirements.
VOLUME OF PRODUCT IN COMMERCE 20,000 capsules
DISTRIBUTION CO

PRODUCT Budesonide 2.0 mg, 5 mL unit dose, Black Vials Only  Product Number:  8590, Compute Rx Bronscho Dose, 
CODE All lot numbers
RECALLING FIRM/MANUFACTURER Computerx Pharmacy, Inc., Stratford, CT,
REASON Subpotent
VOLUME OF PRODUCT IN COMMERCE 6,800 vials
DISTRIBUTION CA, PA, PR, and VA

PRODUCT Thiothixene Capsules, 5 mg, 30 Capsule Box, Rx Only, NDC 61392-175-30, CODE Lot K39006B30, exp. 09/30/07
RECALLING FIRM/MANUFACTURER Heartland Repack Services LLC, Toledo, OH
REASON Mislabeled; Outer carton is labeled as Thiothixene 5 mg Capsules but actually contains blister packs of Metformin Hydrochloride ER 500 mg Tablets.
VOLUME OF PRODUCT IN COMMERCE 145/30 count boxes
DISTRIBUTION Nationwide

PRODUCT
a) Ultram ER Tablets, (Tramadol Hydrochloride) Extended Release Tablets 300mg,
    30 count bottle, Rx Only, NDC 0062-0657-30, 
b) Ultram ER Tablet, (Tramadol Hydrochloride) Extended Release Tablet, 200 mg,
    30 count bottles, Rx Only, NDC 0062-0655-30, 
CODE
a) Lot Number/ Expiration Date: Note: All lots Expire November 2007: 
    Lot Numbers: 06A066P; 06A067P; 06A068P; 06A094P; 06A111P; 06A097P;
    06B012P; 06B013P; 06B023P; 06B024P; 06B025P; 06B031P; 06B002P;
    06B056P; 06B059P; 06B067P; 06B072P;
b) Lot Number:  06A081P, Exp Date:  November 2007
RECALLING FIRM/MANUFACTURER
 Recalling Firm:  Ortho-McNeil Pharmaceutical Inc., Raritan, NJ, 
Manufacturer:  Biovail Corp., Steinbach, Canada.  
REASON Dissolution failure due to a tablet coating defect caused by the tablet printer.
VOLUME OF PRODUCT IN COMMERCE 89,064 bottles
DISTRIBUTION Nationwide

PRODUCT Benzonatate USP Soft Gelatin Capsules, 100 mg, shipped in bulk cartons of 40,000 capsules each, CAUTION:  For Further Manufacturing, Processing or Repackaging Only, Rx ONLY, 
CODE Lot number:  24122208
RECALLING FIRM/MANUFACTURER Banner Pharmacaps, Inc., High Point, NC,
REASON Failed Impurity Specification (6 and 9 month stability)
VOLUME OF PRODUCT IN COMMERCE 1 million capsules
DISTRIBUTION NJ

PRODUCT
a)  Anbesol® Regular Strength Liquid, Oral Anesthetic/10% Benzocaine,
    Cool Mint, 0.41 fl. oz. glass bottle, packaged in blister cards,
    36 bottles/case and may further be packaged for wholesale accounts as
    12 piece display lots. Blister cards are labeled in part  *** Do Not Use if
    plastic blister or backing material is broken or if backing material is
    separated from the plastic*** Bottles are labeled in part ***This bottle
    should be in a sealed outer package. Do Not Use if outer package is missing
    or broken*** Product is sold as ''open stock'', 36 blister carded bottles/case
    and as ''display lots'' with 12 blister carded bottles per clip strip. 
b) Anbesol® Maximum Strength Liquid, Oral Anesthetic/20% Benzocaine,
    0.41 fl. oz. glass bottle, packaged in blister cards, 36 bottles/case and may
    further be packaged for wholesale accounts as 12 piece display lots. Blister
    cards are labeled in part ***Do Not Use if plastic blister or backing material is
    broken or if backing material is separated from the plastic***; Bottles are
    labeled in part ***This bottle should be in a sealed outer package. Do Not Use
    if outer package is missing or broken*** Product is sold as ''open stock'',
    36 blister carded bottles/case and as ''display lots'' with 12 blister carded
    bottles per clip strip, 
CODE
a) Lots A47396, A56081, A65472, A76577, A90503, A94016, B09092, B21466,
    with expiration dates December 2006 through July 2008. Lots A47396, A56081,
    A65472, A76577, A90503, A94016, B09092, B21466, with expiration dates
    December 2006 through July 2008;
b) Lots A56114, A68117, A68118, A68120, A68124, A81724, A90505, A94445,
    B05676, B05677, B05679, B13738, B20342, B25020, B39562, with expiration
    dates September 2006 through January 2008
RECALLING FIRM/MANUFACTURER Richmond Division of Wyeth, Richmond, VA
REASON Packaging Defect; tamper-evident blister seal may separate.
VOLUME OF PRODUCT IN COMMERCE 3,360,973 bottles
DISTRIBUTION Nationwide and US Virgin Island

WEEK ENDING JULY 15

Roxane Laboratories Recalls of a Single Manufacturing Lot of Azathioprine Tablets 

Roxane Laboratories, Inc., is recalling a single manufacturing lot of Azathioprine tablets, USP 50 mg, (NDC 00054-4084-25, Lot 558470A, Exp Mar 2009). Azathioprine is used to help prevent rejection in kidney transplant patients, and can also be used to manage severe rheumatoid arthritis.

It was discovered that a single bottle of Azathioprine tablets from lot 558470A contained Methotrexate tablets USP 2.5 mg.

ADVICE FOR PATIENTS TAKING AZATHIOPRINE TABLETS:

If you have been notified by your pharmacist that you may have received medication from this recalled lot, please return your Azathioprine to your pharmacist.

If you have NOT been notified by your pharmacist, then please take the following steps to verify that you have not received Methotrexate tablets in your Azathioprine prescription:

  1. Visually inspect your Azathioprine tablets.
  2. DO NOT TAKE Azathioprine tablets marked with number 54 323.
  3. If you have Azathioprine tablets marked with number 54 323 immediately contact your pharmacist or physician.
  4. Patients are advised to contact their pharmacist or physician if they have any questions about their prescription or medication.
  5. Requests for additional information should be referred to Roxane Laboratories Technical Product Information at 800-962-8364.

Pharmacists and wholesalers that have any bottles of Azathioprine manufacturing lot 558470A have been instructed to discontinue distribution and use of this lot immediately and contact Capital Returns at 800-950-5479 (menu option 1) for any questions regarding the recall returns. 

Requests for additional information should be referred to Roxane Laboratories Technical Product Information at 800-962-8364.

PRODUCT Mobic (meloxicam), 15 mg. tablets, packaged in 100 tablet bottles,

CODE  Lot ''651237'', expiration date Dec 08; and lot ''651296”, expiration dated Feb 09

RECALLING FIRM/MANUFACTURER

Recalling Firm:  Boehringer Ingelheim Roxane Inc., Columbus, OH,
Manufacturer:  Promeco S.A. De C.V., Xochimilco, Mexico.  

REASON Oversized tablets

VOLUME OF PRODUCT IN COMMERCE 19,521/100 tablet bottles

DISTRIBUTION Nationwide

PRODUCT FIRST AID brand EXTRA STRENGTH NON-ASPIRIN, Acetaminophen 500 mg, 2 tablets per pack, 

CODE Lot 03M847, exp. date 12/06

RECALLING FIRM/MANUFACTURER Generic Pharmaceutical Services, Inc.,Hauppauge, NY,
Manufacturer:  PDK Labs, Inc. Hauppauge, NY.  Firm initiated recall is ongoing.

REASON Lot 03M847, exp. date 12/06

VOLUME OF PRODUCT IN COMMERCE 490,733 pouches, 2 tablets per pouch

DISTRIBUTION Nationwide

PRODUCT Extra Strength Pain Relief PM (acetaminophen 500mg and diphenhydramine HCl 25mg) in bottles of 50 caplets, Pain Reliever, Sleep Aid,

CODE Lot 5ME0438

RECALLING FIRM/MANUFACTURER Perrigo Company, Allegan, MI

REASON Presence of Foreign Particles; acrylic mirror.

VOLUME OF PRODUCT IN COMMERCE 58,920 bottles

DISTRIBUTION Nationwide

PRODUCT Midrin Capsules (Isometheptene Mucate 65 mg, Dichloralphenazone 100 mg. and Acetaminophen 325 mg.) in bottles of 100 capsules, Rx,

CODE Lot 50968B, exp. 7/07

RECALLING FIRM/MANUFACTURER Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI, 

REASON Adulterated Presence of Foreign Tablets; the bottles may contain foreign tablets of the NSAID oxyprozin.

VOLUME OF PRODUCT IN COMMERCE 1,023 bottles

DISTRIBUTION Nationwide

 

PRODUCT Midrin Capsules (Isometheptene Mucate 65 mg, Dichloralphenazone 100 mg and Acetaminophen 325 mg) in bottles of 100 capsules, Rx., 

CODE Lots 50968B, 50969A, 50970A, 51113A, 51166A, 51167A, 51168A, 51169A, 51206A, 51207A and 51308A

RECALLING FIRM/MANUFACTURER Caraco Pharmaceutical Laboratories, Ltd.,Detroit , MI, 

REASON The capsules are brittle and may fracture or break

VOLUME OF PRODUCT IN COMMERCE 12,962 bottles

DISTRIBUTION Nationwide

WEEK ENDING JULY 22

PRODUCT
a) NeutraGard 0.05 % Anticavity Treatment Rinse, 0.05 % Neutral Sodium
Fluoride in 16 oz. clear plastic bottles, Mint flavored, 
b) NeutraGard 0.05 % Anticavity Treatment Rinse, 0.05 % Neutral Sodium
Fluoride in 16 oz. clear plastic bottles, Tropical Blast flavored, 
c) NeutraGard Plus Anticavity Treatment Rinse, 0.02 % Neutral Sodium
Fluoride in 16 oz. clear plastic bottles, Mint flavored, 
d) NeutraGard Plus Anticavity Treatment Rinse, 0.02 % Neutral Sodium
Fluoride in 16 oz. clear plastic bottles, Tropical Blast flavored, 
CODE All lot numbers ending in 06, 07, 08, 09 or 10
RECALLING FIRM/MANUFACTURER Pascal Co., Inc., Bellevue, WA
REASON Microbial Contamination -- Pseudomonas aeruginosa and Burkholderia cepacia
VOLUME OF PRODUCT IN COMMERCE
a) 10,287 bottles;
b) 7,005 bottles;
c) 15,766 bottles;
d) 15,332 bottles
DISTRIBUTION Nationwide and Internationally

PRODUCT Metformin Hydrochloride ER, 500 mg TAB, blister pack of 30 tablets, NDC 61392-419-30, 
CODE Lot K40834D30, Exp. 07/31/2007
RECALLING FIRM/MANUFACTURER Heartland Repack Services LLC, Toledo, OH, REASON Mispacked; outer carton labeled as Metformin Hydrochloride ER may actually contain Thiothixene 5 mg Tablets.
VOLUME OF PRODUCT IN COMMERCE 1,363/30 count boxes
DISTRIBUTION Nationwide

PRODUCT Multi-Vit with Fluoride 0.5 mg and Iron Drops, Multivitamin, Fluoride & Iron Supplement Drops, with Iron, Rx only, 50 mL (1 2/3 fl. oz.). NDC 0603-1453-47,
CODE Lot Number: L089G05A, Exp. 11/07
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals LLC, Huntsville, AL
REASON Subpotent; below specification for Fluoride
VOLUME OF PRODUCT IN COMMERCE 6,802 bottles
DISTRIBUTION Nationwide

Berlex Issues Nationwide Recall of a Single Lot of Ultravist® Injection 370 mgI/mL, 125 mL 

Berlex, Inc. has initiated a nationwide recall of a single lot (No. 41500A) of its intravenous X-ray contrast agent, Ultravist® Injection 370 mgI/mL, 125 mL, (iopromide injection) NDC 50419-246-12, EXP 01/2007, due to the presence of particulate matter in conjunction with crystallization. Berlex is undertaking this recall in consideration of the potential for serious safety problems if the product is administered to patients, including thrombosis of blood vessels, thromboembolism, and injury or infarction of end organs such as heart, kidney, and brain.

Hospitals, imaging centers and other healthcare facilities should not use any of the affected lot number 41500A of Ultravist Injection 370mgI/mL, 125 mL for patient care and should immediately quarantine any product for return. Berlex is working closely with the FDA to communicate and coordinate this recall.

Berlex, Inc. immediately placed remaining inventory of Ultravist 370 mgI/125 mL, lot number 41500A on hold to prevent further distribution of product from this lot. 

Berlex will credit accounts for all returned products from lot number 41500A and shipping costs. Berlex is working with Capital Returns, Inc. to facilitate the return process.

Healthcare providers, imaging centers, wholesalers or patients with questions may contact the company at 1-866-BERLEX-5 or 1-866-237-5395.

WEEK ENDING JULY 29

PRODUCT
Tacrolimus Bulk Powder, Spectrum Catalog #T3192. 
CODE
Lots TA1210 pack letters A-F (Batch #031002);
Lots UD1060 pack letter A (Batch #20050323), UF0298 pack letter A-B (Batch#20050323), UL0964 pack letter A (Batch #20051129), & VB0031 pack letter A-B (Batch# 20051129)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Spectrum Laboratory Products Inc., Gardena, CA
Manufacturer: Changzhou Huaren Chemical Co Ltd, Jiangsu, China (Mainland). 
REASON Subpotent
VOLUME OF PRODUCT IN COMMERCE 465 Containers
DISTRIBUTION Nationwide and South Africa

PRODUCT
a) Zosyn for Injection, (Piperacillin and Tazobactam for Injection), 2.25gram,
Each vial contains piperacillin and tazobactam cryodesiccated powders
for injection equivalent to 2 grams of piperacillin, 0.025 gram tazobactam
and 5.58 mEq (128 mg) of sodium, 10x2.25gram ADD-Vantage Vial,
For IV Use, Rx only, NDC 0206-8452-17 and NDC 0206-8452-18,
b) Zosyn for Injection, (Piperacillin and Tazobactam for Injection), 3.375 gram,
Each vial contains piperacillin and tazobactam cryodesiccated powders for
injection equivalent to 3 grams of piperacillin, 0.375 gram tazobactam,
packaged as 10x3.375 gram ADD-Vantage Vial, For IV Use, Rx only,
NDC 0206-8454-17 and NDC 0206-8854-18, 
c) Zosyn for Injection, (Piperacillin and Tazobactam for Injection), 4.5 gram,
Each vial contains piperacillin and tazobactam cryodesiccated powders for
injection equivalent to 4 grams of piperacillin, 0.5 gram tazobactam, packaged
as 10x4.5 gram ADD-Vantage Vial, For IV Use, Rx only,
CODE
a) NDC 0206-8452-17 ---A70871 (EXP. 3/07), A70872 (EXP. 3/07),
A91364 (EXP. 3/07), A91368 (EXP. 3/07), A91369 (EXP. 3/07),
A91370 (EXP. 4/07), A91379 (EXP. 4/07), A91384 (EXP. 4/07),
A91399 (EXP. 5/07), A91402 (EXP. 5/07), B00210 (EXP. 5/07),
B00214 (EXP. 6/07), B00767 (EXP. 7/07), B00768 (EXP. 6/07),
B06087 (EXP. 6/07), B06088 (EXP. 7/07), B06089 (EXP. 7/07),
B06090 (EXP. 7/07) NDC 0206-8452-18---B42509 (EXP. 3/08),
B42533 (EXP. 3/08);
b) NDC 0206-8454-17 ---- A56107 (EXP. 2/07), A56108 (EXP. 2/07),
A56109 (EXP. 2/07), A70875 (EXP. 3/07), A70876 (EXP. 3/07),
A70877 (EXP. 3/07), A70878 (EXP. 3/07), A70879 (EXP. 3/07),
A70880 (EXP. 3/07), A70881 (EXP. 3/07), A91452 (EXP. 3/07),
A91458 (EXP. 4/07), A91473 (EXP. 4/07), A91572 (EXP. 4/07),
A91573 (EXP. 4/07), A91575 (EXP. 4/07), A91576 (EXP. 4/07),
A91585 (EXP. 4/07), A91586 (EXP. 4/07), A91587 (EXP. 4/07),
A91590 (EXP. 4/07), A91591 (EXP. 4/07), A91592 (EXP. 4/07),
A91593 (EXP. 4/07), A91594 (EXP. 5/07), A91596 (EXP. 5/07),
B00357 (EXP. 5/07), B00358 (EXP. 5/07), B00359 (EXP. 5/07),
B00360 (EXP. 5/07), B00361 (EXP. 5/07), B00362 (EXP. 5/07),
B00363 (EXP. 5/07), B00364 (EXP. 5/07), B00365 (EXP. 5/07),
B00366 (EXP. 5/07), B00367 (EXP. 6/07), B00368 (EXP. 6/07),
B00369 (EXP. 6/07), B00370 (EXP. 6/07), B00371 (EXP. 6/07),
B00372 (EXP. 6/07), B00373 (EXP. 6/07), B00374 (EXP. 6/07),
B00375 (EXP. 7/07), B00376 (EXP. 7/07), B00378 (EXP. 7/07),
(EXP. 7/07), B06176 (EXP. 7/07), B06179 (EXP. 7/07),
B06180 (EXP. 7/07), B06181 (EXP. 7/07), B51100 (EXP. 2/08),
B51101 (EXP. 2/08), B51102 (EXP. 2/08), B51711 (EXP. 1/08),
B51712 (EXP. 1/08), B51713 (EXP. 1/08)
NDC 0206-8854-18 ---- B42530 (EXP. 2/08), B42531 (EXP. 2/08),
B42532 (EXP. 2/08), B42931 (EXP. 2/08), B42932 (EXP. 3/08),
B42934 (EXP. 3/08), B42935 (EXP. 3/08), B42937 (EXP. 3/08),
B42938 (EXP. 3/08), B42940 (EXP. 3/08), B42941 (EXP. 3/08),
B42942 (EXP. 3/08), B45248 (EXP. 3/08);
c) A56143 (EXP. 3/07), A70903 (EXP. 3/07), A70906 (EXP. 4/07),
A92203 (EXP. 5/07), A92205 (EXP. 5/07), A92211 (EXP. 6/07),
B04363 (EXP. 6/07), B04364 (EXP. 6/07), B04365 (EXP. 7/07),
B06357 (EXP. 7/07)
NDC 0206-8855-18 ---- B42510 (EXP. 2/08), B42511 (EXP. 1/08)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Ayerst Laboratories, Philadelphia, PA, 
Manufacturer: Wyeth Pharmaceuticals, Guayama, Puerto Rico. 
REASON Lack of Assurance of Sterility; possible damage to the breakaway cap.
VOLUME OF PRODUCT IN COMMERCE 427,081 vials
DISTRIBUTION Nationwide

PRODUCT Triphasil - 28 Tablets, levonorgestrel and ethinyl estradiol tablets-triphasic regimen), Packages of 3 Dial Packs, Rx only.
CODE Lots: A36954, A36955, A63687, A67660, A67664, A67671, A67680, A86544, A88644, A92651, A93846, A97336, A97337, B15552, B22428, B24181, B31843, B32893, B40792, and B47404
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Ayerst Laboratories, Philadelphia, PA, 
Manufacturer: Wyeth Pharmaceuticals, Guayama, Puerto Rico.
REASON Presence of Foreign Substance; phenol
VOLUME OF PRODUCT IN COMMERCE 459,970
DISTRIBUTION Nationwide

PRODUCT
a) Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 count bottles,
Rx only, 
b) Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 count bottles,
Rx only, 
c) Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 count bottles,
Rx only, 
d) Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), 100 count bottles,
Rx only, 
CODE
a) Pkg. Combo Lot # C04T1921A / 04T14200 / 04T14210;
b) Pkg. Combo Lot # C05T0441A / 05T1130 / 05T1140,
Pkg. Combo Lot # C05T0111A2 (05T7060),
Pkg. Combo Lot # C05T0471A / 05T2250 / 05T2260;
c) Pkg. Combo Lot # C05T0221A4 / 05T7140,
Pkg. Combo Lot # C05T0701A3 / 05T2960,
Pkg. Combo Lot # C05T0711A / 05T3010;
d) Pkg. Combo Lot # C05T0131A2 (05T7330),
Pkg. Combo Lot # C05T0801A2 (05T11190),
Pkg. Combo Lot # C05T0721A / 05T3070 / 05T3080 / 05T3090,
Lot # 05T3051A, Lot # 05T3061A, Lot # 05T3101A, Lot # 05T3111A,
Lot # 05T3201A
RECALLING FIRM/MANUFACTURER
Recalling Firm: ALARA Pharmaceutical Corporation, Caguas, PR, 
Manufacturer: Mova Pharmaceutical Corp., Caguas, Puerto Rico.
REASON Subpotent
VOLUME OF PRODUCT IN COMMERCE 266,236 Bottles (All Lots and Strenghts)
DISTRIBUTION Nationwide

PRODUCT
a) Synthroid Tablets (levothyroxine sodium tablets, USP, 25 mcg (0.025 mg), 100 tablet
bottles, Rx only. 
b )Synthroid Tablets (levothyroxine sodium tablets, USP, 200 mcg (0.2 mg), 100 tablet
bottles, Rx only. 
CODE
a) Lot # 0000354304 Exp. September 1, 2006;
b) Lot # 0000354314 Exp. September 1, 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories MPG, Abbott Park, IL, 
Manufacturer: Abbott Laboratories, Jayuya, PR.
REASON Failed Impurity Specification
VOLUME OF PRODUCT IN COMMERCE 4,633 bottles/100 count
DISTRIBUTION Nationwide

PRODUCT
a) PROCAINAMIDE HCl Capsules USP, 250 mg, 100 count bottles (Yellow),
Rx only. --- NDC 0172-2345-60 
b) PROCAINAMIDE HCl Capsules USP, 500 mg, 100 count bottles (Orange/Yellow),
Rx only. ---- NDC 0172-2347-60 
CODE
a) Lot 2345-119603A Expiration Date July 2006 &
Lot 2345-136349A Expiration Date February 2008;
b) Lot 2347-137085A Expiration date December 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL,
Manufacturer: Ivax Pharmaceuticals, Inc., Cidra, PR.
REASON Discoloration
VOLUME OF PRODUCT IN COMMERCE 24,968 bottles
DISTRIBUTION Nationwide

PRODUCT Nature's Cure brand 3-Day Yeast Infection Treatment, (Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%)] Vaginal Antifungal (Miconazole Nitrate 200 mg per Applicator plus 2% External Vulvar Cream) Combination Pack; 3 prefilled applicators plus external vulvar cream. 
CODE Lot 6CE0201, Exp. 12/08.
RECALLING FIRM/MANUFACTURER Perrigo Company, Allegan, MI
REASON Exceeds Impurity Specification
VOLUME OF PRODUCT IN COMMERCE 2,160 packages
DISTRIBUTION CA

PRODUCT Dr. Hauschka Skin Care Sunscreen Spray for Children and Sensitive Skin, Titanium Dioxide and Zinc Oxide, SPF 20, 5.1 Fl. Oz. Spray Bottle, Dr. Hauschka Skin Care,
CODE All lots codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Doctor Hauschka Cosmetics USA In, Hatfield, MA,
Manufacturer: WALA Heilmittel GmbH, Eckwalden/Bad Boll, Germany, 
REASON Suspension problems; inadequate emulsification
VOLUME OF PRODUCT IN COMMERCE 9,788 bottles
DISTRIBUTION Nationwide and Caribbean

Berlex Recalls Ultravist® Injection 370 mgI/mL

Berlex, Inc., a US affiliate of Schering AG, Germany, is  recalling all lots of its X-ray contrast agent Ultravist® Injection 370 mgI/mL (iopromide injection), as part of a worldwide recall, due to the potential that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of Ultravist (150 mgI/mL, 240 mgI/mL, 300 mgI/mL). Berlex is undertaking this recall in consideration of the potential for serious safety problems if the product is administered to patients, including thrombosis of blood vessels, thromboembolism, and injury or infarction of end organs such as heart, kidney, and brain.

Hospitals, imaging centers and other healthcare facilities should not use any Ultravist® Injection 370 mgI/mL for patient care and should immediately quarantine any product for return.

Berlex is undertaking this recall of Ultravist 370 mgI/mL due to the presence of particulate matter in conjunction with crystallization in consideration of the potential for thromboembolic safety problems if an affected product is administered to patients. On Thursday, July 20, 2006, Berlex voluntarily recalled a single lot of Ultravist® Injection 370 mgI/mL, 125 mL lot number 41500A (NDC 50419-346-12, EXP 01/2007) in the US due to the presence of particulate matter in conjunction with crystallization.

Berlex will credit accounts for all returned Ultravist® Injection 370 mgI/mL product. Berlex is working with Capital Returns, Inc. to facilitate the return process. Those with questions about the return process, please call 1-800-950-5479, menu option 1.

Healthcare providers, imaging centers, wholesalers or patients with other questions may contact the company at 1-866-BERLEX-5 or 1-866-237-5395.