WEEK ENDING AUGUST 4

PRODUCT Dream On (sleep aid), OTC liquid in 16-ounce plastic bottles, marketed and used to enhance sexual activity, improve physicial performance, reduce stress, as a sleep and widely used as a recretional drug.
CODE All lot numbers.
MANUFACTURER Undetermined.
RECALLED BY J.N.G. Sports Distributors, Bloomburg, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY 1,000 bottles were distributed. Firm estimated that very little to no product remained on market at time of recall initiation.
REASON Unapproved new drug product: contains GBL (Gamma-Butyrolactone).

PRODUCT Tricana (tm) Capsules (Metabolic Hormone Analogue), 1g, in bottles of 90, OTC, marketed as a dietary supplement to treat obesity.
CODE Lot Number 00201, EXP 02/02.
MANUFACTURER Undetermined.
RECALLED BY J.N.G. Sports Distributors, Bloomburg, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY Approximately 11,359 bottles were; firm estimated that very little to no product remained on the market at time of recall initiation.
REASON Unapproved new drug product - Contains tiratricol (Thyroid Hormone).

PRODUCT Dimelstat(tm) Capsules, OTC oral dietary supplement in bottles of 60.
CODE Lot #0915, EXP 10/01.
MANUFACTURER Phyytos Nutri-Pharma, Corona, California (contract manufacturer).
RECALLED BY SciQuest Lab, Inc., Brea, California
DISTRIBUTION Alabama, California, Connecticut, Florida, Maryland, New Jersey, New Mexico, Washington state and Canada.
QUANTITY 953 60-capsule bottles were distributed; firm estimated that 100 bottles of the product remained on market at time of recall initiation.
REASON Misbranding: Product fails to declare prescription drug ingredient-glyburide.

PRODUCT Dianolyn(tm) Capsules, OTC oral dietary supplement, in bottles of 30.
CODE Lot #0914 EXP 10/02.
MANUFACTURER Phyytos Nutri-Pharma, Corona, California. (contract manufacturer).
RECALLED BY Diabetic Capital (U.S.) LLC, Alhambra, California (responsible firm)
DISTRIBUTION California, Florida, Georgia, Kansas, Louisiana, Maryland, Missouri, Oregon, Pennsylvania, Texas, Virginia and the District of Columbia.
QUANTITY 10,788 boxes were distributed.
REASON Unapproved new drug - Product contains undeclared prescription ingredient, glyburide.

PRODUCT Artificial Tears, Polyvinyl Alcohol 1.4%, in 1-fluid ounce bottles, OTC ophthalmic solution, under the following labels: Optopics, Rite Aid, Eckerd, and Nex.
CODE Lot #8I101 EXP 9/01.
MANUFACTURER Miza Pharmaceuticals, Inc., doing business as Optopics Laboratories, Fairton, New Jersey.
DISTRIBUTION Oregon, Alabama, West Virginia, New York, California, Utah, Florida, Texas, North Carolina, Pennsylvania, Georgia, Michigan.
QUANTITY 19,755 bottles were distributed.
REASON Lack of assurance of sterility.

PRODUCT Clinipad Sterile Alcohol Pads, 100 per plastic bag. (The Clinipad Pads were packaged for a sole customer who then used the pads as a component in kits manufactured by them).
CODE All lots with numbers beginning with 7,8,9,or 0.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut (responsible firm).
RECALLED BY Lab Aids, Inc., Ronkonkoma, New York (repacker/distributor)
DISTRIBUTION Wisconsin.
QUANTITY 234 packages (100 Clinipad Alcohol Prep Pads per package) were distributed; firm estimated that none of the prep pads remained on market.
REASON Lack of assurance of sterility.

WEEK ENDING AUGUST 11

PRODUCT Pannaz(tm) Tablets, antihistamine-decongestant (Phenylpropanolamine HCl, 75 mg, Chlorpheniramine Maleate 8 mg, Methscopolamine Nitrate 2.5 mg), in 100-tablet bottles, Rx. NDC #0525-0780-01.
CODE Lot #V6337A01 EXP 5/02.
MANUFACTURER Anabolic Laboratories, Inc., Irvine, California.
DISTRIBUTION Undetermined.
QUANTITY 9,493 bottles were distributed.
REASON Lack of complete manufacturing process validation.

PRODUCT Estratab(r) (Esterified Estrogens Tablets, USP), 2.5 mg, in bottles of 100, Rx intended for hormone replacement.
CODE Lot #90654 exp 6/01.
MANUFACTURER Solvay Pharmaceuticals, Inc., Baudette, Minnesota.
RECALLED BY Solvay Pharmaceuticals, Inc., Marietta, Georgia
DISTRIBUTION Nationwide.
QUANTITY 2,282 bottles were distributed.
REASON Tablets did not meet friability specification.

WEEK ENDING AUGUST 18

PRODUCT New Life Colostrum(tm) Cream (unscented moisturizing/repair skin cream), in 2-ounce jars
CODE Lot #A2106990 EXP 1/01.
MANUFACTURER Vege-Kurl, Glendale, California.
RECALLED BY Symbiotics, Inc., Sedona, Arizona
DISTRIBUTION Nationwide, Puerto Rico, Canada.
QUANTITY Undetermined.
REASON Microbial contamination - Pseudomonas putida and Tsukamurella paurometabolum.

PRODUCT Cortef(r) Oral Suspension (hydrocortisone cypionate) 10 mg/5mL, in 4 fluid ounce units
CODE Lot numbers: 62CAT, 63CAT, 64CAT, 23CRW, 24CRW, 04CJX, 05CJX, 19DAJ, 98DXA and 91DTM.
MANUFACTURER Pharmacia Corporation, Kalamazoo, Michigan.
DISTRIBUTION Nationwide, Belgium, Canada, Chile, Ireland, United Kingdom, Uruguay.
QUANTITY 144,357 bottles were distributed.
REASON Product may not always be effective for the treatment of congenital adrenal hyperplasia.

PRODUCT Orasone(tm) 5 Tablets (Prednisone Tablets, USP), 5 mg, in bottles of 1,000, Rx anti-inflammatory agent.
CODE Lot #89335.
MANUFACTURER Solvay Pharmaceuticals, Inc., Baudette, Minnesota.
RECALLED BY Solvay Pharmaceuticals, Inc., Marietta, Georgia
DISTRIBUTION California, Colorado, Connecticut, Minnesota, Missouri, New York, North Dakota, Ohio, South Dakota, Tennessee.
QUANTITY 3,765 bottles were distributed.
REASON Dissolution failure (18 month stability).

PRODUCT Marquee brand Menthol Sore Throat Spray (Pehnol 1.4%), OTC, in 6-fluid ounce bottles.
CODE Lot #9JV0178 EXP 8/01.
MANUFACTURER Perrigo Company, Allegan, Michigan.
DISTRIBUTION Nationwide.
QUANTITY 10,452 bottles were distributed.
REASON Product is missing the tamper resistant protection.

FDA is warning consumers not to purchase or use a product known as Rich's MSM Eye & Ear Drops because it may be contaminated with yeast and Pseudomonas fluorescens - a bacteria that can cause severe, and in rare cases sight-threatening, eye injuries. The distributor of this product, Rich Distributing, of Portland, Oregon is voluntarily recalling the product. Although the scope and volume of the product's distribution is not known at this time, it was sold in one-ounce containers over the Internet and at retail locations to consumers throughout the country.