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Lindane Recalls & Alerts

PRODUCT Lindane Lotion, USP 1%, Rx topical, used for the treatment scabies, in 1 pint bottles sold under the following labels: Pennex, PBI, Goldline, GG, Major, Qualitest, Rugby, Schein. 
Recall #D-327-4.
CODE Lot numbers:  19490A, 19490E, 19516A, 19806A, 19806C,19806E, 19806F, 19866A, 19866C, 19878P, 19878R, 19878T, 19878X.
MANUFACTURER  Pennex Pharmaceuticals, Inc., formerly known as Pharmaceutical Basics, Inc., Morton Grove, Illinois.
RECALLED BY Manufacturer, by letter dated June 29, 1994.  Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY  28,856 bottles were distributed; firm estimates 25% of the product remains on the market.
REASON  Lots 19490, 19516 and 19806 do not meet content uniformity specification.  
Lots 19866 and 19878 are superpotent.
02-18-98, http://www.fda.gov/bbs/topics/ENFORCE/ENF00325.html
Product: Lindane Lotion 1%, in 2 and 16 ounce bottles, an Rx drug indicated for the treatment of patients infested with Sarcoptes scabiei (scabies),  under the Barre-National, Goldline, Rugby and Moore labels.
Recall #D-642-1. 
Code: Lot #03672 (2 oz) EXP 9/92. 
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter August 14, 1991.  Firm-initiated recall ongoing. 
Distribution: Nationwide, Jamaica, Haiti, Guam, The Bahamas, Mexico.
Quantity: 86,688 bottles were distributed; firm estimates 15,145  bottles remain on the market. 
Reason: Presence of mold in some units.
02-18-98, http://www.fda.gov/bbs/topics/ENFORCE/ENF00087.html
PRODUCT     Lindane Lotion, USP 1%, a Rx topical parasiticide for the treatment of patients infested with scabies, in 16 ounce amber plastic bottles, under the following labels:  PBI, Schein,       
Qualitest, Rugby.  Recall #D-090-3.
CODE  Lot #18828 EXP 2/93.
MANUFACTURER Pharmaceutical Basics, Inc., Morton Grove, Illinois.
RECALLED BY  Manufacturer, by telephone, October 23-27, 1993.                 
Firm-initiated recall complete.
DISTRIBUTION  Texas, Ohio, Florida, Alabama, New York, Virginia, Illinois.
QUANTITY 5,987 bottles were distributed; firm estimates none remains on the market.
REASON Non-homogeneous product.
02-18-98, http://www.fda.gov/bbs/topics/ENFORCE/ENF00189.html
 
PRODUCT  Lindane Lotion, USP 1%, an Rx topical, external use only, ectoparasiticide and ovicide, used for the treatment of patients infested with scabies under the following labels: Pennex, in 2 fluid ounce bottles; PBI, in 2 fluid ounce bottles; Goldline, in 2 fluid ounce and in 1 pint bottles; GG, distributed by Geneva Pharmaceuticals, Inc., in 2 fluid  ounce bottles, and in 1 pint bottles; Major, in 1 pint bottles; Qualitest, in 2 fluid ounce bottles; Rugby, in 2 fluid ounce bottles; Schein, in 2 fluid  ounce bottles, and in 1 pint bottles.  Recall #D-022-5.
CODE  Lot numbers 19890, 19901, 19944.
MANUFACTURER Pennex Pharmaceuticals, Inc., formerly known as Pharmaceutical Basics, Inc., Morton Grove, Illinois.
RECALLED BY Pennex Pharmaceuticals, Inc., now known as Morton Grove               Pharmaceuticals, Inc., Morton Grove, Illinois, by letter October 13, 1994.  Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 50,340 2-fluid ounce and 14,919 pint bottles were distributed; firm estimated that less than 10 percent of the product remained on the market at time of recall.
REASON  Product does not meet compendial release criteria.
02-18-98, http://www.fda.gov/bbs/topics/ENFORCE/ENF00345.html
Product:          Various sesame seed products in 50 pound bags:
                  (a) Recleaned Natural Sesame Seed;
                  (b) White Hulled Sesame Seed; 
                  (c) Toasted Hulled Sesame Seed; 
                  (d) Washed Natural Sesame Seed; 
                  (e) Toasted Washed Natural Sesame Seed. 
                  Recall #F-585/589-0.
Code:             L2-08-90, L2-10-90, L2-12-90, L2-13-90, L2-16-90; 
                  L2-20-90, L2-21-90, L2-23-90, L2-26-90, L3-90.
Manufacturer:     Sesame Products, Inc., Paris, Texas.
Recalled by:      McCormick & Company, Inc., Hunt Valley, Maryland, by
                  telephone April 7, 1990.  Firm-initiated recall ongoing.
Distribution:     Nationwide. 
Quantity:         8,156 bags (407,800 pounds) were distributed; firm
                  estimates 304,288 pounds remain on market.
Reason:           Products are contaminated with Lindane/BHC and DDT. 
02-18-98, http://www.fda.gov/bbs/topics/ENFORCE/ENF00056.html

PRODUCT
Spartan brand Blackeye Peas, dry, in 16 ounce bags. Recall #F-535-8.

CODE
9SEP98L.

MANUFACTURER
Arrow Industries, Carrollton, Texas.

RECALLED BY
Spartan Stores, Inc., Grand Rapids, Michigan, 
by letter on December 18, 1997, and by publishing a notice in the weekly store bulletin. Firm-initiated recall complete.

DISTRIBUTION
Indiana, Michigan, Ohio.

QUANTITY
1,272 16-ounce bags were distributed.

REASON
Product contains a lindane pesticide residue greater than FDA's 0.5 ppm action level.

08-06-98, http://www.fda.gov/bbs/topics/ENFORCE/ENF00545.html

 

COUNTRY:  ALGERIA
                                                            EFFECTIVE
COMMODITY       SHIPPER/MANUFACTURER        PESTICIDE(S)        DATE

Dates, Dried    O & D Office National        Lindane        3/16/98
702-2338166-9   De La Dattess
I149722-BUF     Beskra, Algeria
21H[]H05        FEI# 3001338127

07-19-00, http://www.fda.gov/ora/fiars/ora_import_ia9908.html

FDA alerts around the world

PROBLEM : Illegal Pesticide Residues

COUNTRY: ALGERIA

EFFECTIVE COMMODITY SHIPPER/MANUFACTURER PESTICIDE(S) DATE Dates, Dried O & D Office National Lindane 3/16/98 702-2338166-9 De La Dattess I149722-BUF Beskra, Algeria 21H[]H05 FEI# 3001338127

COUNTRY: CANADA

Chana Dal Golden Boy Foods BHC/Lindane 10/7/97 110-5752027-0 8820 Northbrook Court (I138295)-SEA Burnaby,, Canada 24A[][]06 FEI# 1000152603 (Shipper) (See India for Manufacturer: Kirit Foods)

COUNTRY: INDIA

Chana Dal Kirit Foods BHC/Lindane 10/7/97 110-5752027-0 Purana Bazaar/Gen Del (I138295)-SEA Bombay, India 24A[][]06 FEI# 3000268307 (Manufacturer) (See Canada for Shipper: Golden Boy Foods)

COUNTRY: NIGERIA

Ogbono Cereal USIM (Nigeria) Ltd. Lindane 8/27/91 (Whole Grain) Aba Ima, Nigeria 1703390 - NYK

http://www.fda.gov/ora/fiars/ora_import_ia9908.html

 

 

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