MAY 2002

 

WEEK ENDING MAY 4

 

PRODUCT PC SPES, Prostate Formula, Herbal Dietary Supplement, 60 capsules, 320 mg each, over-the-counter sales. Indicated for "prostate health" claim. An herbal dietary supplement containing Chinese herbs (Reishi, Baikal Skullcap, Rabdosia, Dyer's Woad, Mum, Saw Palmetto, San- Qi Ginseng, Licorice).

CODE All lots and all codes.

RECALLING FIRM/MANUFACTURER International Medical Research, dba Botanic Labs Inc., Brea, CA

REASON The product contains the undeclared prescription drug; Warfarin

VOLUME OF PRODUCT IN COMMERCE Unknown.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Cromolyn Sodium Nasal Solution USP, Each spray delivers 5.2 mg cromolyn sodium,(40 mg/mL), 13 mL (100 sprays) and 26 mL (200 sprays) plastic spray pumps containers, Manufactured by Alpharma USPD under the following labels:

Alpharma Cromolyn Sodium Nasal Solution USP                                         

Pfizer BenaMist                                                   

Major Cromolyn Sodium Nasal Solution USP                                

Perfect Choice Cromolyn Sodium Nasal Solution USP                 

Kroger Cromolyn Sodium Nasal Solution USP                                              

Rite Aid Cromolyn Sodium Nasal Solution USP                                            

Walgreens Wal-Crom                                                         

Longs Nasal Allergy Symptom Controller                                                      

Eckerd Cromolyn Sodium Nasal Solution USP                                               

Equate Cromolyn Sodium Nasal Solution USP                                              

Good Neighbor Cromolyn Sodium Nasal Solution USP                               

Leader Nasal Allergy Control Spray                                                

Savon/Osco Cromolyn Sodium Nasal Solution USP                                     

Valu-Rite Nasal Allergy Symptom Controller                                 

CVS Cromolyn Sodium Nasal Solution USP                                                   

Family Pharmacy Nasal Allergy Symptom Controller                   

Quality Choice Cromolyn Sodium Nasal Solution USP                

AAFES Nasal Allergy Symptom Controller                                                    

Discount Drug Mart Cromolyn Sodium Nasal Solution USP                       

CODE

Lot Number Expiry Date

RA1009  31-Jul-02

RA1010  31-Aug-03

RB1068   31-Jul-03

RB1069   31-Jul-03

RB1069   31-Aug-03

RC1136   30-Sep-03

RC1191   30-Sep-03

RC1192   30-Sep-03

RC1193   31-Oct-03

RC1194   31-Oct-03

RH1442  31-Oct-03

RH1444  31-Oct-03

RH1445  31-Oct-03

RH1447  30-Nov-03

RH1448  30-Nov-03

RH1449  30-Nov-03

RH1450  30-Nov-03

RH1451  30-Nov-03

RH1452  30-Nov-03

RH1453  31-Dec-03

RH1454  31-Dec-03

RH1455  31-Dec-03

RH1456  31-Dec-03

RH1457  31-Dec-03

RH1458  31-Dec-03

RH1459  31-Jan-04

RH1460  31-Jan-04

RH1461  31-Jan-04

RH1462  31-Jan-04

RH1463  31-Oct-03

RH1464  31-Oct-03

RH1465  31-Dec-03

RH1466  31-Oct-03

RH1467  31-Oct-03

RH1468  30-Nov-03

RH1469  31-Dec-03

RS0847   31-Jul-03.

RECALLING FIRM/MANUFACTURER Alpharma USPD, Baltimore, MD

REASON Good Manufacturing Practice Deviations (CGMP): Product was manufactured under the same conditions that yielded contaminated

(microbial) product.

VOLUME OF PRODUCT IN COMMERCE 1,423,008 units.

DISTRIBUTION Nationwide.

 

PRODUCT Ranitidine Tablets, USP, 150 mg, Rx only, Unit-Dose Tablets.

CODE Lot #4513-2002, Exp Date 7/31/02.

RECALLING FIRM/MANUFACTURER NCS HealthCare of KY; d.b.a. Vangard Labs, Inc., Glasgow, KY

REASON Product name is mis-spelled on the outer carton label.

VOLUME OF PRODUCT IN COMMERCE 1,056 cartons.

DISTRIBUTION Nationwide.

 

PRODUCT Lovastatin Tablets, USP, 20mg, bottle of 60 tablets, Rx Only.

CODE Lots 220F11, Exp. 6/03 221F11, Exp. 6/03.

RECALLING FIRM/MANUFACTURER Purepac Pharmaceuticals, Elizabeth, NJ

REASON Product failed stability requirement for impurity level.

VOLUME OF PRODUCT IN COMMERCE Lot 220F11 -- 826,080 tablets as 13,768/60 count bottles; Lot 221F11 -- 848,820 tablets as 14,147/60 count bottles.

DISTRIBUTION Nationwide.

 

PRODUCT Urimax tablets in 100 count bottles and 2 tablets patient sample package, Rx

Each tablet contains:

Methenamine 81.60 mg

Sodium Biphosphate 40.80 mg

Phenyl salicylate 36.20 mg

Methylene Blue 10.80 mg

Hyoscyamine Sulfate 0.12 mg

CODE Lots 01101, 10202, 10309, 10406, 10502, 108012, 109001 and 110083.

RECALLING FIRM/MANUFACTURER Integrity Pharmaceutical Corp., Indianapolis, IN

REASON Subpotent for one ingredient (hyoscyamine) at stabilty testing.

VOLUME OF PRODUCT IN COMMERCE 55,800 bottles.

DISTRIBUTION Nationwide.

 

WEEK ENDING MAY 11

 

PRODUCT Junior Strength Motrin Tablets, Grape Flavored, Chewables (Ibuprofen 100 mg) 24 tablets per bottle. 

CODE Lot EBM073 exp. 2/03.

RECALLING FIRM/MANUFACTURER McNeil Consumer & Speciality Pharmaceuticals, Fort Washington, PA

REASON Tablet mix-up; product may contain one or more Women's Tylenol Menstrual Relief Caplets.

VOLUME OF PRODUCT IN COMMERCE 79968 bottles.

DISTRIBUTION Nationwide.

 

PRODUCT Hydrochlorothiazide Tablets, USP, 25 mg, 1000-count Bottles. 

CODE Lot no. 101607A, Exp. date 10/04.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Ivax Pharmaceuticals, Inc., Miami, FL

Manufacturer:  Ivax Pharmaceuticals Caribe, Inc., Cidra, Puerto Rico. 

REASON Tablet mixup with Hydrochlorothiazide 50mg and/or Acyclovir 400 mg tablets.

VOLUME OF PRODUCT IN COMMERCE 17,117 bottles.

DISTRIBUTION Nationwide.

 

PRODUCT Cortizone 5 and Cortizone Kids Creme, (hydrocortisone) 0.5%, Anti-Itch Creme, 0.5, 0.65, 1, 1.3 and 2 ounce tubes, over-the-counter. 

CODE All lots within expiry.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Pfizer Consumer Healthcare, Morris Plains, NJ

Manufacturer:  Pfizer Inc., Parsippany, NJ

REASON Subpotent for Hydrocortisone ingredient (stability).

VOLUME OF PRODUCT IN COMMERCE 2,181,859 tubes

DISTRIBUTION Nationwide and Puerto Rico.

 

PRODUCT Triamcinolone Acetonide Lotion, USP, 0.1%, Rx only, 60 mL plastic bottles. 

CODE

Lot        Expiration Date    

M 405      4/02                                    

M 441      5/02                                    

M 480      6/02                                    

M 504      7/02                                      

M 546      8/02                                    

M 615      10/02                                  

M 623      12/02                                    

M 697      1/03                                       

M 716      2/03                                      

M 749      2/03                                    

M 812      3/03                                      

M 846      5/03                                      

M 911      6/03                                      

M 931      6/03                                      

M 948      7/03                                    

                                        

N 002      8/03               

N 070      10/03                                     

N 088      11/03                                     

N 136      12/03                                     

N 685      4/03                 

N 754      4/03                 

N 796      5/03                

N 230      2/04                 

N 302      4/04                 

N 330      5/04                 

N 423      8/04                

N 424      8/04               

N 480      9/04               

N 499      12/04                                     

N 545      11/04                                   

N 617      1/05               

N 651      3/05               

N 862      7/05               

N 873      7/05               

N 874      7/05               

N 906      8/05               

N 949      10/05                                   

P 017      12/05              

P 018      12/05              

P 026      12/05              

Thames

Qualitest

Rugby, Prod. No. 602-2362

Schein

Goldline

Watson

RECALLING FIRM/MANUFACTURER Thames Pharmacal Co., Inc., Ronkonkoma, NY

REASON Subpotent (stability).

VOLUME OF PRODUCT IN COMMERCE 402,037 x 60 mL bottles total.

DISTRIBUTION Nationwide and Puerto Rico.

 

PRODUCT a) Levothyroxine Sodium tablets, USP, 25 mcg. (0.025 mg) 100 and 1000 tablet bottles, Rx only, under the Qualitest, Vintage

   and URL label.

b) Q-Tuss Tablets, Sustained Release, Rx only, 100 and 500 tablet bottles and bulk drums under the Qualitest and Vintage label.

   Each sustained release tablet contains:

   Phenylephrine HCl            25 mg

   Phenylpropanolamine HCl      50 mg

   Chlorpheniramine Maleate      8 mg

   Hyoscyamine Sulfate        0.19 mg

   Atropine Sulfate           0.04 mg

   Scopolamine Hydrobromide   0.01 mg

c) Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules    (5 mg/2.5 mg) Rx only, 1000 tablet bottles under the

   Qualitest and Vintage label

CODE a) Levothyroxine 0.025 mg. 002129C, 002129D, 002129E

b) Q-Tuss Tablets 039029A, 039029B, 039029C, 039029D, 138039B, 138039C, 142079A, 142079B

c) CDP/Clidinium Bromide Tablets 034128A, 034128B.

RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, NC

REASON Stability; Potency data does not support labeled expiration date.

VOLUME OF PRODUCT IN COMMERCE a) 4,177 bottles Levothyroxine Sodium; b) 21,796 bottles and 495,222 tablets Q-Tuss;

c) 2,693 bottles CDP/Clidinium Bromide.

DISTRIBUTION AL.

 

PRODUCT a) Colchicine Tablets, USP, 0.6 mg, Rx only, 100 and 1000 tablet bottles under the Qualitest label.

b) Phenazopyridine Hydrochloride Tablets, USP, 200 mg, Rx Only, 100 and 1000 tablet bottles under the Qualitest and Vintage label. 

CODE a) 055090A, 055090B, 112070A, 113070A; b) 045070A, 045070B, 045070C.

RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, NC

REASON Unapproved deviations in manufacturing process (CGMP's).

VOLUME OF PRODUCT IN COMMERCE a) 23,096 bottles; b) 8,599 bottles.

DISTRIBUTION AL.

 

Maxair Inhaler Recalled

 

3M Pharmaceuticals Division today announced a voluntary recall of the prescription medication Maxair Inhaler (pirbuterol acetate inhalation aerosol). This is a press-and-breathe metered-dose inhaler. The lot numbers are 000644, 000756, 000947, 001009, 001110, 001111, 010025, 010195, 010283, 010413, 010414, 010482, 010580, 010708, 010709, 011210. The recall has been issued as a precaution to address the remote possibility that a Maxair press-and-breathe aerosol inhaler may stick intermittently and patients may not receive the expected puff of medication. This recall does not affect Maxair Autohaler (pirbuterol acetate inhalation aerosol), a breath-actuated metered-dose inhaler.

 

Patients currently using the Maxair press-and-breathe inhaler are advised to return the product to their pharmacy. 3M is unable to offer patients an exact replacement unit at this time, as the Maxair press-and-breathe inhaler is currently unavailable. Patients can obtain the same medication in a different delivery device. 3M will provide Maxair autohaler (pirbuterol acetate inhalation aerosol), a breath-actuated inhaler (200 mcg pirbuterol/ inhalation), free of charge in exchange for the Maxair press-and-breathe inhaler (200 mcg pirbuterol/inhalation). A physician prescription will be required to obtain a Maxair autohaler or any other inhaler replacement. The recall is being conducted with the knowledge of the U. S. Food and Drug Administration.

 

3M Pharmaceuticals has provided a dedicated toll-free number to respond to questions from patients and physicians. The toll-free number is 1-800-390-1132. This line is available seven days a week, 8:30 a.m. to 5 p.m. EDT.

 

WEEK ENDING MAY 18

 

PRODUCT Recall Extension for the following products:a) Pangestyme Capsules (ETHEX brand) UL20 Pancrelipase Enteric Coated Microtablets Contained in a Capsule, each capsule contains 20,000 USP units lipase, 65,000 USP units amylase, and 65,000 USP units protease, packaged in 100-capsule bottles, RX only;

b) Pangestyme Capsules (Ethex brand) MT16 Pancrelipase Enteric Coated Microtablets Contained in a Capsule, each capsule contains 16,000 USP units lipase, 48,000 USP units amylase and 48,000 USP units protease, packaged in 100-capsule bottles, , RX only;

c. Pangestyme Capsules (ETHEX brand) EC Pancrelipase Enteric Coated Microspheres Contained in Capsules, each dye-free capsule contains 4,500 USP units lipase, 20,000 USP units amylase, and 25,000 USP units protease, packaged in 12-, 100-, and 250-capsule bottles, (12's), (100's) and (250's), RX only. 

CODE

a)  Pangestyme UL20

    Lot 28642, Exp. 04/02

    Lot 28643, Exp. 06/02

    Lot 28653, Exp. 06/02

    Lot 29930, Exp. 06/02

    Lot 29931, Exp. 06/02

    Lot 29932, Exp. 06/02

 Recall extension lot: Lot 34846, Exp 02/03

b)  Pangestyme MT16

    Lot 27478, Exp. 03/02

    Lot 27479, Exp. 03/02

    Lot 27480, Exp. 03/02

    Lot 28639, Exp. 04/02

    Lot 28640, Exp. 04/02

    Lot 28641, Exp. 05/02

    Lot 30245, Exp. 04/02

 Recall extension lot: Lot 35703, Exp. 03/03

c)  Pangestyme EC

    Lot 27487, Exp. 05/02

    Lot 27488, Exp. 05/02

    Lot 27489 (250-ct.), Exp. 05/02

    Lot 27777, Exp. 06/02

    Lot 27778, Exp. 07/02

    Lot 27779 (250-ct.), Exp. 07/02

    Lot 27780 (250-ct.), Exp. 08/02

    Lot 30882, Exp. 07/02

    Lot 30883, Exp. 07/02

    Lot 30934, Exp. 07/02

Recall extension lots:

    Lot 30884, Exp 12/02

    Lot 31558, Exp 12/02

    Lot 32562, Exp 01/03

    Lot 34399, Exp 01/03

    Lot 34796, Exp 01/03

    Lot 34835, Exp 03/03

    Lot 35986, Exp 04/03

    Lot 35987, Exp 04/03  

Lot 36499, Exp 05/03.

RECALLING FIRM/MANUFACTURER Recalling Firm: ETHEX Corp., St. Louis, MO

Manufacturer:  KV Pharmaceutical Co., St. Louis, MO.

REASON Subpotency (Stability).

VOLUME OF PRODUCT IN COMMERCE UL12 - 4,581 btls; UL18 - 3,474 btls; MT16 - 10,899 btls; UL20 - 8,728 btls; EC - 50,070 btls.

DISTRIBUTION Nationwide.

 

PRODUCT Bactroban Ointment, brand of mupirocin, 2% Ointment, 22 gram tubes, Rx only, distributed under the SmithKline Beecham

Pharmaceuticals, Philadelphia, PA label.

CODE

Lot No.       Exp. date:

50-1B25       11/30/2002

29-1B25        9/30/2002     

62-1B25       11/30/2002

84-1B25        2/28/2003

94-1B25        3/31/2003

106-1B25       4/30/2003.

RECALLING FIRM/MANUFACTURER Glaxo SB Pharmco Puerto Rico, Inc., Cidra, Puerto Rico

REASON Microbial Contamination; presence of Pseudomona fluorescens, Burkholderia pickettii or Ralstonia paucula.

VOLUME OF PRODUCT IN COMMERCE 194, 580 units (Tubes 22 grams).

DISTRIBUTION Nationwide.

 

PRODUCT a) Mivacron Injection (mivacurium chloride), Equivalent to 20    mg/10 mL (2 mg/mL) mivacurium, 10 mL Single-dose Fliptop

   Vial, Rx only;

b) Nimbex Injection (cisatracurium besylate), Equivalent to 10mg/5mL (2 mg/mL) cisatracurium, 5 mL Single-dose Vial,    Rx only;

c) Nimbex Injection (cisatracurium besylate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple-dose Vial, Rx only.

CODE a) lot 0H2493, exp. 05/02; b) lot 0E2030, exp. 12/01; c) lot 0E2033, exp. 01/02.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Abbott Laboratories, Inc., Hospital Products Division, Abbott Park, IL

Manufacturer:  DSM Catalytica Pharmaceuticals, Inc., Greenville, NC. 

REASON Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE a) 107,360 vials; b) 52,610 - 5 ml vials; c) 102,690 - 10 ml vials.

DISTRIBUTION Nationwide.

 

PRODUCT Diflucan (Fluconazole) Injection, 200 mg (2mg/mL), Iso-Osmotic Sodium Chloride Diluent, 100 mL saline bag, Viaflex Plus single

dose, sterile, nonpyrogenic, Rx only, Roerig, a div of Pfizer brand.

CODE Lot no. PS109439 Exp. date 5/03

RECALLING FIRM/MANUFACTURER: Recalling Firm: Pfizer, Inc., New York, NY

Manufacturer:  Baxter Health Corp. Jayuya, PR. 

REASON Lack of assurance of sterility; the port tube may be leaking.

VOLUME OF PRODUCT IN COMMERCE 17,243 units.

DISTRIBUTION Nationwide.

 

GlaxoSmithKline Alerts Patients, Pharmacists and Physicians to Watch for Third-Party Tampering that Incorrectly Labels Ziagen® as Combivir®

 

GlaxoSmithKline announced today that the company has received four reports of suspect bottles containing 60 tablets of Combivir® (lamivudine plus zidovudine) that actually contained another medicine, Ziagen® (abacavir sulfate) Tablets. The company has determined that counterfeit labels for Combivir® Tablets were placed on two bottles of Ziagen® and labels on another two bottles are suspect. Both medicines are used as part of combination regimens to treat HIV infection.

 

The incidents appear to be isolated and limited in scope. No injuries or adverse reactions have been reported. Company tests have shown no problems with the medicine itself. GlaxoSmithKline and the U.S. Food and Drug Administration are both investigating. The company also is contacting health-care providers and pharmacists to alert them to the situation and is alerting patients to check their medicine to be sure they have received the correct tablets.

 

Pharmacists, physicians and patients should immediately examine the contents of each Combivir® bottle to confirm they do not contain Ziagen® tablets. The two kinds of tablets are easily distinguishable. Combivir® is a white capsule-shaped tablet engraved with "GX FC3" on one side; the other side of the tablet is plain. Ziagen® is a yellow capsule-shaped tablet engraved with "GX 623" on one face; the other side is plain. The Combivir® label shows a color photo of the tablet.

 

The risk to patients is primarily due to the fact that approximately 5% of individuals who receive abacavir sulfate in Ziagen® or Trizivir® (abacavir sulfate, lamivudine and zidovudine) Tablets have developed a potentially life-threatening hypersensitivity reaction. Symptoms generally resolve after discontinuing the medication, however, patients who have had a hypersensitivity reaction to Ziagen® are advised to never take the medication again. Patients taking Combivir® would not have been advised about the hypersensitivity reaction and how to take Ziagen® safely because Combivir® does not contain abacavir sulfate. Patients who have had a hypersensitivity reaction to abacavir yet take Ziagen® or Trizivir® again experience more severe symptoms within hours that may include life-threatening hypotension (lowering of the blood pressure) and death. In addition, the replacement of Combivir® which contains two antiviral drugs with Ziagen®, a single antiviral, may decrease the effectiveness of a patient's treatment regimen. Patients should always confirm they have the right medication; for patients taking Combivir® this is especially important now.

 

"While we cannot determine the extent of counterfeit labeling, we believe this unfortunate situation can be addressed by watchful pharmacists checking products before dispensing them and careful patients double-checking their medications," said Peter Traber, senior vice president clinical development and medical affairs at GSK. "Both patients and pharmacists can easily recognize the difference between the two tablets and can identify if they have received the wrong medicine before they take it." These steps should minimize the risk to patients. Involved in the counterfeit labeling cases were 60-count bottles of Combivir® Tablets, which contain 150-milligrams of lamivudine and 300 milligrams of zidovudine, and 60-count bottles of 300-milligram tablets of Ziagen®.

 

Patients who have any question about their medicine should take it immediately to their pharmacist to have it checked. Pharmacists with questionable medicine should keep the bottle and report their concerns to GSK at 888-825-5249. Patients with questions should also call 888-825-5249.

 

Serono Issues Notification of Counterfeit Serostim®

 

Serono, Inc. has recently become aware of a counterfeit lot of Serono's Serostim® [somatropin (rDNA origin) for injection]. The counterfeit material has been packaged to appear as drug product lot number S810-1A1. This is not a legitimate Serostim® lot number. Serono has notified the appropriate regulatory and law enforcement authorities of this matter.

 

Preliminary information appears to indicate that the counterfeit material may have been distributed via the Internet. However, Serono is also alerting pharmacists to the counterfeit material and recommending that they examine Serostim® prior to dispensing to ensure that the package does not bear lot number S810-1A1. The counterfeit material was neither manufactured nor distributed by Serono. Therefore, it cannot be assumed that the counterfeit material is either safe or effective.

 

Serono continues to cooperate with regulatory and law enforcement authorities to identify and prosecute individuals involved in drug counterfeiting. Serostim® is approved in the U.S. for the treatment of AIDS wasting. Patients seeking information regarding Serostim® may call Serono at 1-888-275-7376.

 

WEEK ENDING MAY 25

 

PRODUCT VERSED Syrup (midazolam HCl) CIV, 118 ml (2mg/mL) bottles, Rx only. 

CODE Lot U0009-50 exp. 4/2003 Lot U0010-50 exp. 4/2003.

RECALLING FIRM/MANUFACTURER Recalling Firm: Hoffmann La Roche Inc., Nutley, NJ

Manufacturer: Hoffmann-LaRoche, Nutley, NJ. 

REASON Potency, product crystallization causing a lack of uniformity in potency.

VOLUME OF PRODUCT IN COMMERCE 13,122 bottles.

DISTRIBUTION Norway.

 

PRODUCT a) Endure 420 Cida-Stat Foam (chlorhexidine gluconate) 2%, 27 oz   (800 mL) bottles

b) Endure 420 Cida-Stat Surgical Scrub/Healthcare Personnel Hand Wash (chlorhexidine gluconate) 2%, 4 oz, 18 oz and 1000 mL

   bottles

c) Endure 400 Scrub-Stat 4 Surgical Scrub (chlorhexidine gluconate) 4%, 18 oz and 1000 mL bottles

d) Dial Surgical Scrub (chlorhexidine gluconate) 4% Antimicrobial Solution, 4 oz and 1 gallon bottles.  

CODE a) Lots: L011291, L021291, L041291, L092901 and L111601; b) Lot L091501; c) Lot L083191; d) Lot L083191;

RECALLING FIRM/MANUFACTURER Ecolab Inc., Huntington, IN

REASON Subpotent for chlorhexidine gluconate (stability).

VOLUME OF PRODUCT IN COMMERCE 3700 cases/12-800 ml. bottles per case.

DISTRIBUTION Nationwide.

 

PRODUCT a) 8.5% FreAmine III (Amino Acid) Injection, 1000 mL glass intravenous infusion bottles, Rx only

b) 10% FreAmine III (Amino Acid) Injection, 1000 mL glass intravenous infusion bottles, Rx only.

CODE Catalog Numbers S9030-SS and S9010-SS  Batch Numbers J2C029 and J2C030.

RECALLING FIRM/MANUFACTURER B. Braun Medical, Inc., Irvine, CA

REASON Packaging/ Labeling mix-up (correctly labeled bottles of 8.5% FreAmine III were found in cartons incorrectly labeled as 10% FreAmine III)

VOLUME OF PRODUCT IN COMMERCE 11,478.

DISTRIBUTION Nationwide.