OCTOBER 2002

WEEK ENDING OCTOBER 5

PRODUCT MS Contin Tablets (morphine sulfate) controlled-release, 15 mg, 25 count blister packs, 100 and 500 count bottles.
CODE
5H31 (500's)Exp 7/04
5H32 (25's) Exp 7/02
5H33 (25's) Exp 7/02
5H34 (25's) Exp 7/02
5H35 (25's) Exp 7/02
5H36 (100's) Exp 7/04.
RECALLING FIRM/MANUFACTURER Recalling Firm: The Purdue Frederick Co., Norwalk, CT.
Manufacturer: The P.F. Laboratories, Inc., Totowa, NJ.
REASON Tablet mixup; 30 mg tablets may be in bottles and/or blister packs labeled as containing 15 mg tablets.
VOLUME OF PRODUCT IN COMMERCE 4,571 bottles of 500's; 4,968 bottles of 100's; and 26,455 blisters of 25's.
DISTRIBUTION Nationwide and the Dominican Republic.

PRODUCT Quinine Sulfate Tablets, USP, 260 mg, 100 count bottle, Rx only
CODE Lot No. Exp. Date 3001-105631A Apr/04.
RECALLING FIRM/MANUFACTURER Recalling Firm: Ivax Pharmaceuticals, Inc., Miami, FL
Manufacturer: Ivax Pharmaceutical Caribe, Inc., Cidra, Puerto Rico.
REASON Tablet mixup; a bottle labeled as containing Quinine Sulfate tablets was found to contain Quinine Sulfate tablets and one tablet of Labetalol 100 mg, an antihypertensive.
VOLUME OF PRODUCT IN COMMERCE 12,000 bottles.
DISTRIBUTION Nationwide.

PRODUCT Benadryl Allergy/Sinus Headache Caplets co-packaged with a Bonus 4 mL bottle of Visine Tears (Diphenhydramine Hydrochloride
12.5 mg, Pseudoephedrine Hydrochloride 30 mg, Acetaminophen 500 mg), 24 count package

CODES

Codes: Lot Numbers:

01222CD01 Exp Date: 4/2003

01222CM01 "

01322CD01 "

01322CM01 "

01422CN01 "

01522CD01 "

01522CN01 "

RECALLING FIRM/MANUFACTURER Recalling Firm: Pfizer Consumer Healthcare R&D Morris Plains, NJ.
Manufacturer: Pfizer, Inc., Vega Baja, PR.
REASON Mispackaged; promotional packages labeled as containing Benadryl Allergy/Sinus Headache Caplets co-packaged with a bonus 4mL sample of Visine Tears may actually contain Benadryl Severe Allergy/Sinus Headache Caplets.
VOLUME OF PRODUCT IN COMMERCE 2270 boxes of 24 caplets.
DISTRIBUTION AR

PRODUCT a) HALLS Sugar Free Cough Drops (Menthol 5.8 mg) 25 DROPS per bag, Mountain Menthol; b) HALLS Sugar Free Cough Drops (Menthol 5 mg) 25 DROPS per bag, Black Cherry.
CODE a) Lot # 0722E, Exp. 2/7/2004; b) Lot #00832E, Exp. 3/8/2004.
RECALLING FIRM/MANUFACTURER Recalling Firm: Adams USA (Div. of Warner Lambert, a Subsidiary of Pfizer, Inc.), Parsippany, NJ

Manufacturer: Parke Davis & Co. Limited, Manchester M26 2QT, England.
REASON Product may contain metal particles.
VOLUME OF PRODUCT IN COMMERCE a) 1053 cases; b) 189 cases.
DISTRIBUTION Nationwide.

PRODUCT a) Listerine Essential Care Gel Toothpaste, 0.9 oz tube (Eucalyptol 0.738%, Menthol 0.340%, Methyl salicylate 0.480%, Thymol 0.511%, Sodium monofluorophosphate 0.76% (0.13% Fluoride Ion); b) Listerine Essential Care Tartar Control Gel Toothpaste, 0.9 oz tube, (Eucalyptol 0.738%, Menthol 0.340%, Methyl salicylate 0.480%, Thymol 0.511%, Sodium monofluorophosphate 0.76% (0.13% Fluoride Ion).
CODE All Lots packaged as follows: Professional Samples -- Not for Retail Sale

Trial Size Tartar Control Gel Case UPC 1 03 12547 43450 5 Case containing 72/0.9 ounce tubes

Trial Size Gel Case UPC 1 03 12547 43470 3 Case containing 72/0.9 ounce tubes. Promotional Items as an on-pack with Listerine 1.0 L and 1.5 L (Gold, CoolMint, Fresh Burst, Tartar Control, Mixed Displays) Bottles.
RECALLING FIRM/MANUFACTURER Recalling Firm: Pfizer, Consumer Healthcare Group, Morris Plains, NJ.
Manufacturer: Accupac, Inc., Mainland, PA.
REASON Subpotent; active ingredient Methyl salicylate (stability).
VOLUME OF PRODUCT IN COMMERCE 12,649,365 tubes.
DISTRIBUTION Nationwide and Puerto Rico.

PRODUCT Oxygen, USP, High Pressure Cylinders, Compressed.
CODE Lot OP895 and Lot OP901.
RECALLING FIRM/MANUFACTURER Oxygen Support Systems, Riverside, NJ.
REASON Subpotent.
VOLUME OF PRODUCT IN COMMERCE 12.
DISTRIBUTION NJ and PA.

FDA Issues Cyber Letter to Yellow Jackets Promoter

FDA announced that it has issued a Cyber Letter (a letter sent via email to notify a company of potential violations) to the operator of an internet web site for promoting and selling Yellow Jackets, an herbal product, as an alternative to illicit street drugs.

Yellow Jackets are promoted as a substitute for controlled substances. According to the promoter's web site, they contain ephedra and other herbal ingredients, including kola nut extract (a source of caffeine). There does not appear to be any legitimate drug use for this product, and its sale as a substitute for controlled substances would be illegal.

FDA is aware that some street drug alternatives are being marketed as dietary supplements. FDA does not believe that street drug alternatives are intended to be used to supplement the diet. Accordingly, street drug alternatives do not meet the definition of a dietary supplement. Yellow Jackets, described on the web site as herbal XTC, could pose a serious risk to consumers.

"Consumers should not purchase or use these or similar products available through the Internet or elsewhere," said FDA Deputy Commissioner, Dr. Lester M. Crawford. "FDA will continue its efforts to protect American consumers from dangerous and fraudulent internet companies who would sell illegal products that present risks to public health."

FDA has issued this "cyber" letter to the internet address of Yellow Jackets promoter, Mr. Xoch Linnebank of the Netherlands and noted that the continued sale of Yellow Jackets and other products as substitutes for controlled substances to U.S. citizens may be illegal.

FDA's "cyber" letters provide foreign operators with an explanation of the statutory provisions that govern interstate commerce of drugs in the United States, as well as a warning that future shipments of their products to this country may be detained at the border and subject to refusal of entry. Copies of each "cyber" letter are sent to regulatory officials in the country in which the operator is based and to other individuals and companies involved in the operation of the web site.

In March of 2000, FDA made available the document, "Guidance for Industry Street Drug Alternatives." This document is available at the Internet web site, http://www.fda.gov/cder/guidance/3602fnl.htm. It explains FDA's policy on products that are promoted as street drug alternatives. Consumers who want information about online drug sales, or, who wish to report web sites that they believe are promoting illegal products, can contact the FDA through its Web site at www.fda.gov/oc/buyonline/.

WEEK ENDING OCTOBER 12

PRODUCT NX Stage Dialysis Solution, Formula A, Optioncare brand, 3000 mL bags, Rx Only.
CODE All lot codes are under recall.
RECALLING FIRM/MANUFACTURER Option Care, Inc., Columbia, MD.
REASON Microbial contamination.
VOLUME OF PRODUCT IN COMMERCE 3134 bags.
DISTRIBUTION IN, CA, MA, NJ, VA, MA and MS.

PRODUCT a) Vancocin HCl Injection (sterile vancomycin hydrochloride, USP) IntraVenous, Equiv. to 500 mg Vancomycin, VIAL No. 657, traypak of 25, Lyophilized, Rx;

b) Vancocin HCl (sterile vancomycin hydrochloride, USP) IntraVenous, Equiv. to 1 g Vancomycin, VIAL No. 7321,traypak of 25, Lyophilized, Rx only;

c) Vancocin HCl for Injection (vancomycin hydrochloride for injection, USP) IntraVenous, Equiv. to 10 g Vancomycin, 100 mL vials, Lyophilized, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Rx (VIAL No. 7355);

d) Vancomycin Hydrochloride for Injection, USP, Equiv. to 10 g Vancomycin, 100 mL vial, PHARMACY BULK PACKAGE, NOT FOR DIRECT INFUSION, Rx only, Lyophilized, AmeriNet Choice (Trademark) label, Vancomycin Hydrochloride for Injection, USP, NDC 0002-9509-01;
e) NEBCIN (Tobramycin for Injection, USP) Equiv. to 1.2 g Tobramycin, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Rx only, VIAL No. 7040, Traypak of 6;
f) Tobramycin for Injection, USP, Equivalent to 1.2 g Tobramycin, per 30mL, Multiple Dose Vial,(40 mg/mL) traypaks of 6, Rx only, NOVAPLUS, USA Novation, the supply company of VHA and UHC, and NOVAPLUS are trademarks of Novation,LLC;
g) Dobutrex Solution (Dobutamine Injection, USP) Equiv. to 250 mg, Dobutamine per 20 mL, Single Dose Vial, Rx, 20 mL VIAL No. 7175, For I.V. Use Only;
h) Dobutamine Injection, USP, Equivalent to 250 mg Dobutamine per 20 mL, 20 mL Single Dose Vial, Rx only, NOVAPLUS, For I.V. Use Only, USA;
i) GEMZAR (Gemcitabine HCl For Injection) 200 mg equivalent to base, For I.V. use only, Sterile Single Use Vial, Rx, VIAL 7501;
j) GEMZAR (Gemcitabine HCl For Injection) 1 g equivalent to base, For I.V. use only, Sterile Single Use Vial, Rx, VIAL No. 7502;
k) Dolophine Hydrochloride (Methadone Hydrochloride Injection,USP) 10 mg per mL, Multiple Dose Vial;
l) Brevital Sodium (Methohexital Sodium for Injection, USP),500 mg, Anesthetic Barbiturate, Multiple Dose Vial, Rx Only;
m) Brevital Sodium (Methohexital Sodium for Injection, USP) 2.5 g, Multiple Dose Vial, Anesthetic Barbiturate, Rx Only.
CODE Lot (Exp. Date)
Vancocin: USA Distribution
500 mg 4MK94M (1-Aug-02) and 4MP18N (1-Oct-02)
1 gm 5MG16W (1-Apr-03), 5MA16M (1-Feb-03), 4MT59T (1-Sep-02), 4MT60M (1-Sep-02) and 4MX34M (1-Oct-02)
10gm 4MN09M (1-Sep-03), 4MH51M (1-May-03), 5MZ89M (1-Nov-04), and 5MZ89N (1-Nov-04)
Foreign Distribution: 4MP20XA (1-Oct-02), 4MP20XB (1-Oct-02), 5MA16M (1-Feb-03), 5MG16R (1-Apr-03), 5MG16U (1-Apr-03), 5MG16T (1-Apr-03), 4MX34P (1-Oct-02), 4MN09N (1-Sep-03), 4MP20P (1-Oct-02), 4MP20R (1-Oct-02), 4MP20S (1-Oct-02), 4MP20V (1-Oct-02), 4MP20W (1-Oct-02), 5MU91M (1-Nov-03), 5MX28M (1-Nov-03), 5MX28P (1-Nov-03), 4MK15N (1-Sep-02), 4MK15P (1-Sep-02), 5MG16S (1-Apr-03), 5MG16V (1-Apr-03), 4MP20Y (1-Oct-02), 4MP16P (1-Sep-02), 5NA70M (1-Nov-03), 4MP20T (1-Oct-02), 4MP20X (1-Oct-02), 4MP20U (1-Oct-02), and 4MK15R (1-Sep-02)
Nebcin: USA Distribution 1.2 gm 4MK03M (1-Aug-03), 4MP21M (1-Sep-03), 4MT55M (1-Jan-04), 3MY51M (1-Oct-02), 3NG79M (1-Mar-03), 4MS30M (1-Sep-03), 4MT54M (1-Oct-03), 4MT55M (1-Jan-04), 4MW41M (1-Feb-04), 5MG75M (1-Jun-04), 5MH80M (1-Jun-04), 4MR25M (1-Sep-03) and 5MM86M (1-Jun-04), 5MX32M (1-Feb-04)
Foreign Distribution: 3NG79M (1-Mar-03), 4MK03M (1-Aug-03), 4MR25M (1-Sep-03), 4MW41M (1-Feb-04), 5MG75M (1-Jun-04), 5MH80M (1-Jun-04), 5MM86M (1-Jun-04), 4MT54N (1-Oct-03), 4MT55N (1-Jan-04) and 5MH80N (1-Jun-04)
Dobutrex: USA Distribution: 5MF45P (1Apr-03), 4MY39P(1-Feb-03), 5MA94M(1-Feb-03), 5MM00M (1-Jun-03), 4MX96P (1-Jan-03) and 5MW48N (1-Oct-03)
Foreign Distribution: 4MY39N (1-Feb-03), 5MF45N (1-Apr-03), 5MX82M (1-Feb-04), 5MX82N (1-Feb-04), 5MX82P (1-Feb-04), 5MX82R (1-Feb-04), and 5MW48M (1-Oct-03)
Gemzar: USA Distribution:
200 mg 4MS42M (1_Sep-02)
1gm 4MT36M (1-Sep-02), 4MT37M (1-Sep-02), 4MT63M (1-Oct-02), 5MC30M (1-Mar-03), 5MG22M(1-May-03) and 5NG88M (1-Mar-04)
Foreign Distribution: 4MT63M (1-Oct-02), 5MG22N (1-May-03), 4MT62M (1-Sep-02), 4MT62T (1-Sep-02), 4MT62P (1-Sep-02), 4MT62N (1-Sep-02), 4MT62S (1-Sep-02)
Brevital Sodium USA Distribution
2.5 mg/20mL vials 5MT41M (8/1/2003) 4NF766M (6/1/2003)
500mg/50mL vials 3MN14M, 3MN14N (9/1/2002) 3MN33M, 3MN33P (10/1/2002) 3MN34P, 3MN34R, 3MN34S (10/1/2002) 3MY48M, 3MY48N, 3MY48P (11/1/2002) 4MP65M (9/1/2002) 4MA84M, 4MA84N, 4MA84P (11/1/2002) 4MF88M, 4MF88N (6/1/2003) 4MJ99M (7/1/2003)
5MP44M, 5MP44N (8/1/2003) 5MU47M, 5MU47P, 5MU47R (12/1/2003) 5MN77M, 5MN77N (10/1/2003)
Dolophine Hydrochloride USA Distribution
10mg/mL 20 mL vial 5MP72M (Jun-03) 5MW93M (Sep-03).
RECALLING FIRM/MANUFACTURER Eli Lilly and Co., Indianapolis, IN.
REASON Particulates and/or cracked vials.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide and Internationally.

PRODUCT Oxygen, USP, Compressed, type D, E and M aluminum cylinders.
CODE All lots.
RECALLING FIRM/MANUFACTURER Tri-State Home Care Inc., Pittsburgh, PA
REASON Good Manufacturing Practice (GMP) deviations, including but not limited to, failure to test for purity and identity.
VOLUME OF PRODUCT IN COMMERCE 37 cylinders.
DISTRIBUTION PA.

PRODUCT Allegra 60 mg (Fexofenadine HCl Capsules), 14 and 60 count bottles, Rx only.
CODE Lot no. 1044325, exp. 5/2004 and Lot no. 1048818, exp. 10/2004.
RECALLING FIRM/MANUFACTURER Recalling Firm: Pharmaceutical Corp. of America, Indianapolis, IN.
Manufacturer: Aventis Pharmaceuticals, Inc., Kansas City, MO.
REASON Label mixup; bottles labeled as containing 60mg capsules actually contain 60mg tablets.
VOLUME OF PRODUCT IN COMMERCE 17 units.
DISTRIBUTION CA and MI.

PRODUCT Liquid Oxygen, USP, Refrigerated, transfilled into 46 liter Cryogenic Home Vessels, Rx Only.
CODE Serial numbers: 02182013, 01253095, 01190133, 01190112, 01190110, 02204388, 01180794, 01180787, 01180187, 01150090, 01150072.
RECALLING FIRM/MANUFACTURER Laurel Home Healthcare, Ann Arbor, MI.
REASON Good Manufacturing Practice (GMP) deviations, including but not limited to, lack of all batch records and use of an improperly calibrated oxygen analyzer.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION MI.

PRODUCT a) MEIJER ORAL SALINE Laxative (Monobasic Sodium Phosphate 2.4g, Dibasic Sodium Phosphate 0.9g) Sugar Free, 3 FL OZ
(90 mL) MULTI-DOSE CONTAINER, LEMON FLAVOR; b) Oral Saline Laxative Sav-on Osco brand by Albertson's (Monobasic Sodium Phosphate 2.4g, Dibasic Sodium Phosphate 0.9g) 3 FL OZ (90 mL) Multi-Dose Container, Lemon Flavor.
CODE
Lot # 2093L Expiration Date: 04/04
Lot # 2114L Expiration Code: 04/04
Lot # 2119L Expiration Code: 04/04
Lot # 2155L Expiration Code: 06/04.
RECALLING FIRM/MANUFACTURER Unico Holdings, Inc., Lake Worth, FL.
REASON Mislabeling; outer carton dosage instructions (by manufacturer) incorrectly declare dosage for Adults & children as "12 years & under" rather than correctly as "12 years & over"
VOLUME OF PRODUCT IN COMMERCE 1398/12 bottle cases.
DISTRIBUTION MI and AZ.

Pharmacia Corporation Announces Voluntary Recall of Lunelle™ Monthly Contraceptive Injection

Pharmacia Corporation announced today that the company is initiating a voluntary recall of Lunelle™ Monthly Contraceptive Injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension) in prefilled syringes due to a lack of assurance of full potency and possible risk of contraceptive failure. As a precaution, Pharmacia is voluntarily recalling all Lunelle prefilled syringe lots currently on the market. Lunelle packaged in vials is not affected by this recall, nor is any other Pharmacia contraceptive product.

Lunelle is a combined hormonal contraceptive (like the oral contraceptive pill) that is administered to women by a healthcare professional as a monthly injection. A sub-potent dose of Lunelle may not be effective in preventing pregnancy. Women who have been using Lunelle as their contraceptive are advised to seek the advice of their healthcare professional regarding alternative methods of birth control and to use an additional barrier method of birth control (such as male or female condoms, diaphragm, or spermicide) until beginning a new form of hormonal contraception.

Pharmacia is committed to the integrity and safety of its products and is undertaking this voluntary recall with the full knowledge of the Food and Drug Administration. The affected lots were distributed in the United States, Puerto Rico and the U.S. Virgin Islands during 2002 and all physicians, pharmacies, clinics and wholesalers who received these lots are being notified. For further information healthcare professionals may call the Pharmacia medical information service on 1 800 323 4204. Patients may call the Pharmacia patient information service on 1-888-691-6813.

WEEK ENDING OCTOBER 19

PRODUCT a) Methylprednisolone Acetate for Injection, 40 mg/mL,1 ml, single dose vial;
b) Methylprednisolone Acetate for Injection, 80 mg/mL,1 ml, single dose vial;
c) Baclofen for Injection, Preservative-Free, 2 mg/mL,10 mL vial;
d) Baclofen for Injection, Preservative-Free, 50 mcg/mL, 1 mL vial;
e) Baclofen for Injection, Preservative-Free, 500 mcg/mL,20 mL vial.
CODE All lot codes are under recall.
RECALLING FIRM/MANUFACTURER Portage Pharmacy (aka Innovative Professional Services), Portage, MI

REASON Microbial contamination; Penicillium mold, Methylobacterium, and/or Mycobacterium chelonae.
VOLUME OF PRODUCT IN COMMERCE Approx. 791 vials.
DISTRIBUTION MI.

PRODUCT Nardil Tablets (Phenelzine Sulfate Tablets, USP) 15 mg, 100 count bottles, Rx only.
CODE Lot 354O1L exp. 9/30/02.
RECALLING FIRM/MANUFACTURER Recalling Firm: Pfizer, Inc., New York, NY. Manufacturer: Pfizer, Inc., Lititz, PA.
REASON Subpotent; (9 month stability).
VOLUME OF PRODUCT IN COMMERCE 19013 bottles.
DISTRIBUTION Nationwide.

FDA SEIZES DIETARY SUPPLEMENTS WITH DRUG CLAIMS

US Marshals seized dietary supplements making drug claims from the Humphrey Laboratories of Lake Oswego, Oregon, doing business as Kirkman Laboratories. U.S. Marshals seized hundreds of bottles of Kirkman's HypoAllergenic Taurine Capsules after FDA determined that these products made unsubstantiated claims to treat autism, a neurobehavioral disorder that begins in early childhood.

FDA seized these products because they violate the Federal Food, Drug, and Cosmetic Act. In accordance with the Act, all dietary supplement products' labeling must be truthful and not misleading and may not make any claims that the product will cure, mitigate, treat, or prevent disease. Consequently, the claims that the capsules treat autism caused the firm's product to be a misbranded food and an unapproved new

"FDA will continue to pursue products that violate the law," said FDA Deputy Commissioner Dr. Lester M. Crawford. "This seizure emphasizes our commitment to protect the public health by keeping the marketplace free from products that make medical claims not substantiated by scientific evidence."

This seizure was the result of FDA's investigation of the firm's Internet site. To date no illnesses have been reported in association with consumption of this product. FDA will continue to identify and take appropriate enforcement actions against fraudulently marketed dietary supplement products that make unsubstantiated medical claims in their labeling.

WEEK ENDING OCTOBER 26

PRODUCT a) Testosterone Cypionate for Injection, 200 mg/mL,1 mL, 5 mL and 10 mL vials;
b) Hyaluronidase for Injection, 25 Units/mL, 1 mL vial (Preservative free);
c) Hyaluronidase for injection, 150 Units/mL, 1 mL and 5 mL vials (preservative-free), FOR OFFICE, CLINIC, OR HOSPITAL USE ONLY;
d) Hyaluronidase for Injection 150 Units/mL, 10 mL multi-dose vial for injection, FOR OFFICE, CLINIC, OR HOSPITAL USE ONLY;
e) Betamethasone for Injection 6 mg/mL 1 mL vial or 5 mL multi-dose vial, For Office, Clinic, or Hospital Use Only;
f) Hydroxyprogesterone Caproate Long-acting IM Injection, 250 mg/ml, 5 ml vial;
g) Furosemide for Injection, 10 mg/mL, 4 mL and 10 mL vials;
h) Estrone for Injection, 5 mg/mL, (Multiple-dose vial), 5 mL vials;
i) Prostaglandin E1 for Injection, 20 mcg/mL, 10 mL vials;
j) Papaverine 30 mg/mL, phentolamine 0.5 mg/mL and prostaglandin E1 10 mcg/mL for Injection, Store in Refrigerator, 10 ml vials;
k) Corticotropin LA for Injection, 80 Units/mL, Refrigerate Product, 5 mL vials;
l) Meperidine for Injection, 25 mg/mL, 1 mL vial (preservative-free);
m) Meperidine for Injection, 50 mg/mL, 1 mL vial (preservative-free);
n) Estradiol Cypionate/Testosterone Cypionate for Injection, 4mg/100 mg/mL, 10 mL Multiple-dose vial;
o) Estradiol Cypionate for Injection, 5 mg/mL, 10 mL Multiple-dose vial;
p) Sodium Tetradecyl Sulfate 3% Solution for Injection, 10 mL Multiple-dose vial3;
q) Triamcinolone Acetonide for Injection, 4 mg/mL, 10 mL Multiple-dose vial, For Office, Clinic, or Hospital Use Only;
r) Phenol for Injection, 5%, 5 mL vials3; s) Progesterone in Sesame Oil for Injection, 50 mg/mL, 10 mL Multiple-dose vial.
CODE All lot codes for all products.
RECALLING FIRM/MANUFACTURER Portage Pharmacy (aka) Innovative Professional Services), Portage, MI

REASON Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE Approx. 175 vials.
DISTRIBUTION MI.

PRODUCT 1) Quad Tann Pediatric Suspension, Breckenridge Pharmaceutical, Inc., Each 5 ml contains: Carbetapentane Tannate 30 mg, Chlorpheniramine Tannate 4 mg, Ephedrine Tannate 5 mg and Phenylephrine Tannate 5 mg., One Pint (473 mL), Rx Only.
1a) Quad Tann Pediatric Suspension, URL, One Pint (473 mL), Each 5 ml contains: Carbetapentane Tannate 30 mg, Chlorpheniramine Tannate 4 mg, Ephedrine Tannate 5 mg and Phenylephrine Tannate 5 mg Rx Only;
2) Trionate Suspension, One Pint,(473 mL),Breckenridge Pharmaceutical, Inc., Each 5 ml contains: Carbetapentane Tannate 30 mg, Chlorpheniramine Tannate 4 mg., Rx only,
2a) Trionate Suspension, One Pint (473 mL), URL, Each 5 ml contains: Carbetapentane Tannate 30 mg, Chlorpheniramine Tannate 4 mg, Rx Only;
3) Tri Tann Pediatric Suspension,One Pint (473 mL), Each 5 mL contains: Phenylephrine Tannate 5 mg, Chlorpheniramine Tannate 2 mg, Pyrilamine Tannate 12.5 mg, Rx Only;
4) Duotan Suspension, Antihistamine/Decongestant, Strawberry/Banana Flavor, 4 fl. oz. and 16 Fl. oz. bottles, Each 5 ml contains: Chlorpheniramine Tannate 4.5 mg,Pseudoephedrine Tannate 75 mg, Breckenridge Pharmaceutical, Inc., Rx Only(16 Fl.oz) (4 Fl. oz.).
CODE 1) Quad Tann Pediatric : T0907, T0929, T1023, T1102, T1208, T1218, U0815, U0905, U0917, U0919, U1019, U1205, U1207, U1527, U1114.
2) Trionate Suspension : AF004, U0620, U0828, U0820, U0823, U0831, U0908, U0911, U0913, U1023, U1030, U1103, U1106, U1107, U1108, U1109,
U1322, U1331, U1404, U1407, U1408, U0218, U0309.
3) Tri Tann Pediatric Suspension : T1116, T1120, T1127, U1421.
4) Duotan Suspension 4 fl oz: AE028, AD010, U1007, U1017, U1030, U1126, U1217, U1314, U1425, U1504;
Duotan Suspension 16 Fl oz: AD010, AE004, AE028, AF012, U1002, U1007, U1017, U1025, U1030, U1126, U1128, U1217, U1314, U1316,
U1425, U1504, U1513.
RECALLING FIRM/MANUFACTURER DSC Products, Inc. (dba DCS Laboratories), Muskegon, MI

REASON Lack of assurance of stability.
VOLUME OF PRODUCT IN COMMERCE Approx. 142,000 bottles.
DISTRIBUTION Nationwide.

PRODUCT Triamcinolone Acetonide Cream USP, 0.1%, NET WT. 1 lb. (453.6g) jar.
CODE Lot# 110080.
RECALLING FIRM/MANUFACTURER Alpharma USPD, Inc., Lincolnton, NC.
REASON Super-Potent.
VOLUME OF PRODUCT IN COMMERCE 5724 units.
DISTRIBUTION Nationwide.

PRODUCT Isosorbide Mononitrate EXTENDED-RELEASE Tablets, 30 mg, 100 and 500 count bottles, PUREPAC, Rx Only.
CODE

Lots Exp.

135E1 7/2003

136E1 7/2003

137E1 7/2003

138E1 7/2003

139E1 7/2003

140E1 7/2003

173F1 8/2003.

RECALLING FIRM/MANUFACTURER Recalling Firm: Alpharma USHP (formerly known as Purepac), Elizabeth, NJ

REASON Dissolution Failure; 6 hour release (9 month stability).
VOLUME OF PRODUCT IN COMMERCE 105340 bottles of 100's; 11381 bottles of 500's.
DISTRIBUTION Nationwide.