February 26, 1997 97-09
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Doxycycline Hyclate, 100 mg Capsules, USP, in
bottles of 50 and 500, Rx, a broad spectrum
antibiotic. Recall #D-118-7.
CODE Various labels and lot numbers as follows:
(a) Aligen Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules
distributed by Aligen Independent
Laboratories, Inc., Jackson Hole, Wyoming
Lots: 55301M3 EXP 10/98 and 55310M3 EXP
10/98
(b) Aligen Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules
distributed by Aligen Independent
Laboratories, Inc., Jackson Hole, Wyoming
Lots: 55304H3 EXP 08/98 and 55303M3 EXP 10/98
(c) Doxychel Doxycycline Hyclate 100 mg
Capsules in bottles of 50 capsules, Rachelle
Laboratories, Inc., Culver, Indiana, Lot:
55303R3 EXP 11/98
(d) Doxychel Doxycycline Hyclate 100 mg
Capsules in bottles of 500 capsules, Rachelle
Laboratories, Inc., Culver, Indiana,
Lots: 55302M3 EXP 10/98, 55305M3 EXP 10/98,
55306M3 EXP 10/98, 55308M3 EXP 10/98, 55309M3
EXP 10/98, and 55308R3 EXP 11/98
(e) Geneva Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules
distributed by Geneva Pharmaceuticals, Inc.,
Broomfield, Colorado, Lots: 55310M3 EXP 10/98
and 55306R3 EXP 11/98
(f) Geneva Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules
distributed by Geneva Pharmaceuticals, Inc.,
Broomfield, Colorado, Lots: 55307H3 EXP 08/98
and 55303R3 EXP 11/98
(g) Halsey Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules,
Halsey Drug Co., Inc., Brooklyn, New York
Lots: 55306H3 EXP 08/98, 55310M3 EXP 10/98,
55303R3 EXP 11/98, and 55306R3 EXP 11/98
(h) Halsey Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules,
Halsey Drug Co., Inc., Brooklyn, New York
Lots: 55306H3 EXP 08/98, 55304H3 EXP 08/98,
55307H3 EXP 08/98, 55308H3 EXP 08/98, 55301K3
EXP 09/98 and 55307A4 EXP 11/98
(i) Major Doxycycline Hyclate 100 mg capsules,
USP in bottles of 50 capsules, Major
Pharmaceutical Corp., Chicago, Illinois, and
labeled "Manufactured by Halsey Drug Co.,
Inc., Brooklyn, N.Y." Lots: 55306H3 EXP
08/98, 55309H3 EXP 08/98, 55310M3 EXP
10/98 and 55306R3 EXP 11/98
(j) Major Doxycycline Hyclate 100 mg capsules,
USP in bottles of 500 capsules distributed by
Major Pharmaceutical Corp., Chicago, Illinois
and labeled "Manufactured by Halsey Drug Co.,
Inc., Brooklyn, N.Y." Lots: 55307H3 EXP
08/98, 55308H3 EXP 08/98, 55302M3 EXP 10/98
and 55306R3 EXP 11/98
(k) Mason Doxycycline Hyclate 100 mg capsules,
USP in bottles of 500 capsules distributed by
Mason Distributors, Inc., Hialean, Florida,
and labeled "Mfd. by Halsey Drug Co., Inc.,
Brooklyn, N.Y." Lots: 55303M3 EXP 10/98 and
55301R3 EXP 11/98
(l) Moore Doxycycline Hyclate 100 mg capsules,
USP in bottles of 50 capsules distributed by
h.l. Moore Drug Exchange, New Britain,
Connecticut, and labeled "Mfg. by Halsey Drug
Co., Inc., Brooklyn, N.Y." Lots: 55306H3 EXP
08/98, 55309H3 EXP 08/98, 55310M3 EXP 10/98
and 55306R3 EXP 11/98
(m) Moore Doxycycline Hyclate 100 mg capsules,
USP in bottles of 500 capsules distributed by
h.l. Moore Drug Exchange, New Britain,
Connecticut, and labeled "Mfg. by Halsey Drug
Co., Inc., Brooklyn, N.Y." Lots: 55304H3 EXP
08/98, 55308H3 EXP 08/98, 55301K3 EXP 09/98,
55302M3 EXP 10/98
(n) Parmed Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules
distributed by Parmed Pharmaceuticals, Inc.,
Niagara Falls, New York, and labeled "Mfg. by:
Halsey Drug Co., Inc., Brooklyn, N.Y."
Lot: 55310M3 EXP 10/98
(o) Parmed Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules
distributed by Parmed Pharmaceuticals, Inc.,
Niagara Falls, New York, and labeled "Mfg. by:
Halsey Drug Co., Inc., Brooklyn, N.Y."
Lot: 55302M3 EXP 10/98
(p) Qualitest Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules and
labeled "Mfg. for: Qualitest Products, Inc.,
Huntsville, Alabama. Mfg. by: Halsey Drug
Co, Inc., Brooklyn, N.Y." Lots: 55309H3 EXP
08/98, 55310M3 EXP 10/98 and 55306R3 EXP 11/98
(q) Qualitest Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules and
labeled "Mfg. for: Qualitest Products, Inc.,
Huntsville, Alabama. Mfg. by: Halsey Drug Co.,
Inc., Brooklyn, N.Y." Lots: 55306H3 EXP
08-98, 55303M3 EXP 10/98, 55301R3 EXP 11/98,
55303R3 EXP 11/98 and 55306R3 EXP 11/98
(r) URL Doxycycline Hyclate 100 mg capsules,
USP in bottles of 50 capsules and labeled
"Manufactured for United Research
Laboratories, Inc., Bensalem, Pennsylvania
Mfd. By Halsey Drug Co., Inc., Brooklyn, N.Y."
Lots: 55306H3 EXP 08/98 and 55309H3 EXP 08/98
(s) URL Doxycycline Hyclate 100 mg capsules,
USP in bottles of 500 capsules and labeled
"Manufactured for United Research
Laboratories, Inc., Bensalem, Pennsylvania
Mfd. By Halsey Drug Co., Inc., Brooklyn, N.Y."
Lots: 55308H3 EXP 08/98 and 55301K3 EXP 09/98
(t) Warner Chilcott Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules and
labeled "Manufactured for: Warner Chilcott
Labs, Div of Warner-Lambert Co., Morris
Plains, New Jersey By: Halsey Drug Co., Inc.,
Brooklyn, NY" Lots: 94953W EXP 08/98 and
55301M3 EXP 10/98
(U) Warner Chilcott Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules and
labeled "Manufactured for: Warner Chilcott
Labs, Div of Warner-Lambert Co., Morris
Plains, New Jersey By: Halsey Drug Co., Inc.,
Brooklyn, NY" Lots: 92183W EXP 08/98, 55304M3
EXP 10/98 and 55311R3 EXP 11/98.
MANUFACTURER Houba, Inc., a subsidiary of Halsey Drug
Company, Inc., Culver, Indiana.
RECALLED BY Manufacturer, by letter dated January 3,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12 million capsules were distributed.
REASON Stability is not assured through expiration
date (capsules may be excessively brittle).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
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PRODUCT Nitrostat Sublingual Tablets, 0.4 mg
(Nitroglycerin Tablets USP), in bottles of 25,
Rx indicated for the acute relief of an attack
or prophylaxis of angina pectoris due to
coronary artery disease. Recall #D-119-7.
-5-_CODE Lot #01385F EXP 7/97.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert
Company, Morris Plains, New Jersey, by letter
on January 28, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 23,750 bottles were distributed.
REASON Product lacks stability (failed content assay
at the 15-month stability timepoint -- 86.6%;
SPEC is 90-110%).
Alan W Davidson
General Secretary, International Pharmaceutical Federation
a.davidson@fip.nl or visit our web site at
http://www.pharmweb.net/pwmirror/pw9/fip/pharmweb92.html
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