Lindane Product Recalls
| 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 |
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