FDA Recalls &
Court Actions
|
Nov. 23,
2005
|
|
CLASS
II
|
|
Amino
Acid Cervical Cream
|
|
Urea 8.34%,
methionine 0.83%, inositol 0.83%, cystine 0.35%, net
wt. 2-3/4 ounce tube 77.96 grams & applicator, Rx
only, NDC 60267-234-14, Lots: 40803, exp. 06/06;
40804, exp. 06/06; 41008, exp. 07/06; 50524, exp.
04/07; 50525, exp. 07/07; 50608, exp. 04/07 &
50609, exp. 04/07.
|
|
Manufacturer:
|
Sheffield
Laboratories, New London, CT.
|
|
Recalled
by:
|
Hope
Medical Enterprises, Inc., Scottsdale, AZ, by
telephone and letter dated Nov. 3, 2005.
Firm-initiated recall is ongoing.
|
|
Distribution:
|
Nationwide
and PR; 37,514 tubes.
|
|
Reason:
|
Method
validation deviations for finished product
testing.
|
|
Recall
number:
|
D-024-6.
|
|
Micronefrin (racemic
epinephrine)
|
|
Each 100 mL
contains racemic methylamino-ethanol catechol 2.25 g,
For inhalation topical pulmonary chemotherapy (TPC),
mucosal decongestant and bronchodilator, 15 mL and 30
mL bottles, Rx only, made in U.S.A., NDC
12136-009-11, Lots: 297, exp. 03/05; 398, exp. 12/05;
399, exp. 06/06; 401, exp. 02/07; 297, exp. 03/05;
398, exp. 12/05; 399, exp. 06/06; 401, exp.
02/07.
|
|
Manufacturer:
|
Viasys
Respiratory Care, Inc., Palm Springs, CA.
|
|
Recalled
by:
|
Manufacturer, by letters dated Oct. 15,
2005. Firm-initiated recall is ongoing.
|
|
Distribution:
|
Nationwide
and internationally; 64,517 bottles.
|
|
Reason:
|
Lack of
assurance of sterility; product not manufactured
sterile as required by the FDA sterility requirement
for aqueous-based drug products for oral
inhalation.
|
|
Recall
number:
|
D-021-6.
|
|
CLASS
III
|
|
NeoTect Kit
|
|
For the
preparation of technetium Tc-99m depreotide
injection, diagnostic for intravenous use, single use
vial, Rx only, NDC 45567-0515-3, Lot 30121, exp.
04/06.
|
|
Manufacturer:
|
Rentschler
Biotechnologie GmbH & Co. KG, Laupheim,
Germany.
|
|
Recalled
by:
|
CIS-US,
Inc., Bedford, MA, by telephone on Oct. 19, 2005 and
by letter on Oct. 20, 2005. Firm-initiated recall is
ongoing.
|
|
Distribution:
|
Nationwide;
73 vials.
|
|
Reason:
|
Exceeds
impurity specification.
|
|
Recall
number:
|
D-023-6.
|
|
Oxycodone and Acetaminophen
Capsules
|
|
USP, 5
mg/500 mg capsules, Rx only, 100 count bottles,
Qualitest brand, NDC 0603-4997-21, Lot
C0821203A.
|
|
Manufacturer:
|
Vintage
Pharmaceuticals, Inc., Charlotte, NC.
|
|
Recalled
by:
|
Manufacturer, by letter on Oct. 10, 2005.
Firm-initiated recall is ongoing.
|
|
Distribution:
|
Nationwide;
2,768 bottles (100 capsules/bottle).
|
|
Reason:
|
Dissolution
failure (21 month stability)
|
|
Recall
number:
|
D-022-6.
|
|
