JANUARY 2001

WEEK ENDING JANUARY 5

PRODUCT Collyrium Eye Wash, (Boric Acid) in 4-fluid ounce (118 mL) bottles, OTC aqueous ophthalmic solution indicated for cleansing the eye, under the Wyeth and Bausch & Lomb labels.

CODE Wyeth Laboratories, Inc. labeled product bearing lot numbers: 3981543 EXP 6/01; 3982156 EXP 6/01; 3982217 EXP 6/01; Bausch & Lomb labeled product bearing lot numbers: 3982224 EXP 7/01; 3982225 EXP 8/01; 3982226 EXP 9/01; 3991526 EXP 1/02; 3991172 EXP 1/02; 3991269 EXP 4/02; 3990414 EXP 7/02.

MANUFACTURER Wyeth-Ayerts Pharmaceuticals, Inc., Rouses Point, New York (contract manufacturer).

RECALLED BY Bausch & Lomb, Inc., Rochester, New York

DISTRIBUTION Nationwide.

QUANTITY Volume of product in commerce:

Lot 3981543: 26,256 bottles

Lot 3982156: 79,032 bottles

Lot 3982217: 78,636 bottles

Lot 3982224: 78,684 bottles

Lot 3982225: 78,612 bottles

Lot 3982226: 78,888 bottles

Lot 3991526: 78,828 bottles

Lot 3991172: 77,484 bottles

Lot 3991269: 78,348 bottles

Lot 3990414: 49,656 bottles.

REASON Phenol contamination (labeling component migration across the container wall).

WEEK ENDING JANUARY 12

PRODUCT Premarin Conjugated

a) Premarin (r) tablets (conjugated estrogens tablets),0.625 mg, 100 & 1,000 count bottles; 

b) Premarin (r) tablets (conjugated estrogens tablets), 1.25mg, 100 & 1,000 count bottles;

c) Premarin (r) tablets (conjugated estrogens tablets, 2.5mg, 100 count bottles.

CODE STRENGTH: 0.625 mg/100 count bottles:

a) Lot #9990086 Exp. 9/02, Lot #9990086 Exp. 12/03, Lot #999029U Exp. 11/03, Lot #9990585W Exp. 11/03,

STRENGTH: 0.625 mg/1,000 count bottles: Lot #9990086 Exp. 9/02, Lot #9980299 Exp. 11/02;

STRENGTH 1.25 mg/100 count bottles/NDC #0046-0866-81:

b) Lot #9980874 Exp. 2/03; STRENGTH: 1.25 mg/1,000 count bottles: Lot #9980874 Exp. 2/03; STRENGTH: 2.5 mg/100 count bottles046-0865-81:

c) Lot #9990175 Exp. 10/03.

MANUFACTURER Wyeth-Pharmaceuticals Co., Gauyama, Puerto Rico.

RECALLED BY National Pharmpak Svcs, Incorporated, Zanesville, Ohio

DISTRIBUTION Nationwide and New Mexico, Puerto Rico.

QUANTITY 108,394 bottles were distributed.

REASON Manufacturer failed to meet USP dissolution specifications for Conjugated Estrogen.