FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
11/04/1992
RECALLS AND FIELD CORRECTIONS: Novmber 4, 1992
DRUGS -- CLASS III
92-45
PRODUCT Acne Day Lotion, an OTC drug packaged in 2 ounce and 16 ounce
containers, a non-PABA sunscreen. Recall #D-050-3.
CODE Lot #2786.
MANUFACTURER Chemolee Labs, Inc., Irving, Texas.
RECALLED BY Manufacturer, by telephone August 1, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION California.
QUANTITY Firm estimates none remains on the market.
REASON Presence of mold.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Platelets, Pheresis;
(d) Cryoprecipitated AHF; (e) Fresh Frozen Plasma;
(f) Recovered Plasma. Recall #B-015/020-3.
CODE Unit numbers: (a) 90-27258, 90-27262, 90-27263,
90-27265, 90-27266, 90-27267, 90-27268, 90-27269,
90-27270, 90-27271, 90-27272, 90-27274, 90-27275,
90-27277, 90-27278, 90-27279, 90-27280, 90-27283,
90-27285, 90-27286, 90-27287, 90-27288, 90-27289,
90-27291, 90-27292, 90-27293, 90-27294, 90-27295,
90-27296, 90-27297, 90-27298, 90-27299, 91-21020,
91-21021, 91-21022, 91-21023, 91-21024, 91-21025,
91-21026, 91-21027, 91-21029, 91-21030, 91-21031, 91-21032,
91-21033, 91-21034, 91-21035, 91-21036, 91-21037, 91-21038,
91-21039, 91-21040, 91-21041, 91-21042, 91-21043, 91-21044,
91-21045, 91-21046, 91-21048, 91-21049, 91-21050, 91-21051,
91-21052, 91-21053, 91-21054, 91-21055, 91-21056, 91-21057,
91-21058, 91-21059, 91-21060, 91-21061, 91-21062, 91-21063,
93-47805, 93-47806, 93-47807, 93-47809, 93-47810, 93-47811,
93-47812, 93-47813, 93-47814, 93-47815, 93-47816, 93-47817,
93-47818, 93-47819, 93-47820, 93-47821, 93-47822, 93-47823,
93-47825, 93-47826, 93-47827, 93-47828, 93-47829, 93-47830,
93-47831, 93-47832, 93-47833, 93-47835, 93-47836, 93-47837,
93-47838, 93-47839, 93-47840, 93-47841, 93-47842, 93-47843,
93-47844, 93-47845, 93-47846, 93-47847, 93-47848, 93-47849,
93-47850, 93-47851, 93-47852, 93-47853, 93-47854, 93-47855,
93-47856, 93-47857, 93-47859, 93-47860, 93-47861, 93-47862,
93-47863, 93-47864, 93-47865, 93-47866, 93-47870, 93-47871,
93-47872, 93-47873, 93-47874, 93-47875, 93-47876, 93-47877,
93-47878, 93-47879, 93-47880, 93-47881, 93-47882, 93-47883,
93-47884, 93-47885, 93-47886, 93-47887, 93-47888, 93-47889,
93-47890, 93-47891, 93-47892, 93-47893, 93-47894, 93-47895,
93-47896, 94-09461, 94-09462, 94-09463, 94-09464, 94-09465,
94-09466, 94-09467, 94-09469, 94-09470, 94-09471, 94-09472,
94-09473, 94-09474, 94-09475, 94-09476, 94-09477, 94-09478,
94-09481, 94-09482, 94-09483, 94-09484, 94-09485, 94-09486,
94-09487, 94-09488, 94-09490, 94-09491, 94-09492, 94-09495,
94-09496, 94-09497, 94-09498, 94-09499, 94-09500, 94-09501,
94-09502, 94-09503, 94-09504, 94-09505, 94-09506, 94-09507,
94-09508, 94-09509, 94-09510, 94-09511, 94-09512, 94-09513,
94-09514, 94-09515, 94-09517, 94-09518, 94-09519;
(b) 91-21022, 91-21024, 91-21025, 91-21026, 91-21027, 91-21029,
91-21030, 91-21032, 91-21033, 91-21035, 91-21036, 91-21037,
91-21038, 91-21039, 91-21040, 91-21041, 91-21042, 91-21043,
91-21044, 91-21045, 91-21046, 91-21048, 91-21049, 91-21050,
91-21051, 91-21052, 91-21053, 91-21054, 91-21055, 91-21056,
93-47856, 93-47857, 93-47859, 93-47860, 93-47861, 93-47862,
93-47863, 93-47864, 93-47865, 93-47866, 93-47870, 93-47871,
93-47872, 93-47873, 93-47874, 93-47875, 93-47876, 93-47877,
93-47878, 93-47879, 93-47880, 93-47881, 93-47882, 93-47883,
93-47884, 93-47885, 93-47886, 93-47887, 93-47888, 93-47889,
93-47890, 93-47891, 93-47892, 93-47893, 93-47894, 93-47895,
93-47896, 94-09461, 94-09462, 94-09463, 94-09464, 94-09465,
94-09466, 94-09467, 94-09469, 94-09470, 94-09471, 94-09474,
94-09475, 94-09476, 94-09477, 94-09478, 94-09481, 94-09482,
94-09484, 94-09485, 94-09486, 94-09487, 94-09488, 94-09491,
94-09492, 94-09495, 94-09496, 94-09497, 94-09498, 94-09499,
94-09500, 94-09501, 94-09502, 94-09503, 94-09504, 94-09505,
94-09506, 94-09507, 94-09508, 94-09509, 94-09510, 94-09511,
94-09512, 94-09513, 94-09514, 94-09515, 94-09516, 94-09518,
94-09519, 94-09520;
(c) 90-27257, 90-27260, 90-27261, 90-27264, 90-27273, 90-27276,
90-27281;
-2-
(d) 90-27279, 90-27280, 90-27287, 90-27289, 90-27293, 90-27295,
90-27298;
(e) 90-27271, 90-27272, 90-27274, 90-27275, 90-27278, 90-27284,
90-27286, 90-27288, 90-27291, 90-27296, 90-27297, 90-27299,
91-21061, 94-09473, 94-09490, 94-09517;
(f) 90-27258, 90-27259, 90-27262, 90-27263, 90-27265, 90-27267,
90-27268, 90-27269, 90-27270, 90-27279, 90-27280, 90-27287,
90-27289, 90-27292, 90-27293, 90-27295, 90-27298, 91-21020,
91-21021, 91-21022, 91-21023, 91-21024, 91-21025, 91-21026,
91-21027, 91-21029, 91-21030, 91-21031, 91-21032, 91-21033,
91-21034, 91-21035, 91-21036, 91-21037, 91-21038, 91-21039,
91-21040, 91-21041, 91-21042, 91-21043, 91-21044, 91-21045,
91-21046, 91-21048, 91-21049, 91-21050, 91-21051, 91-21052,
91-21053, 91-21054, 91-21055, 91-21056, 91-21057, 91-21058,
91-21059, 91-21060, 91-21062, 91-21063, 93-47805, 93-47806,
93-47807, 93-47809, 93-47810, 93-47811, 93-47812, 93-47813,
93-47814, 93-47815, 93-47816, 93-47817, 93-47818, 93-47819,
93-47820, 93-47821, 93-47822, 93-47823, 93-47825, 93-47826,
93-47827, 93-47828, 93-47829, 93-47830, 93-47831, 93-47832,
93-47833, 93-47834, 93-47835, 93-47836, 93-47837, 93-47838,
93-47839, 93-47840, 93-47841, 93-47842, 93-47844, 93-47845,
93-47846, 93-47847, 93-47848, 93-47849, 93-47850, 93-47851,
93-47852, 93-47853, 93-47854, 93-47855, 93-47856, 93-47857,
93-47859, 93-47860, 93-47861, 93-47862, 93-47863, 93-47864,
93-47865, 93-47866, 93-47870, 93-47871, 93-47872, 93-47873,
93-47874, 93-47875, 93-47876, 93-47877, 93-47878, 93-47879,
93-47880, 93-47881, 93-47882, 93-47883, 93-47884, 93-47885,
93-47886, 93-47887, 93-47888, 93-47889, 93-47890, 93-47891,
93-47892, 93-47893, 93-47894, 93-47895, 93-47896, 94-09461,
94-09462, 94-09463, 94-09464, 94-09465, 94-09466, 94-09467,
94-09469, 94-09470, 94-09471, 94-09472, 94-09474, 94-09475,
94-09476, 94-09477, 94-09478, 94-09481, 94-09482, 94-09483,
94-09484, 94-09485, 94-09486, 94-09487, 94-09488, 94-09491,
94-09492, 94-09495, 94-09496, 94-09497, 94-09498, 94-09499,
94-09500, 94-09501, 94-09502, 94-09503, 94-09504, 94-09505,
94-09506, 94-09508, 94-09509, 94-09510, 94-09511, 94-09513,
94-09514, 94-09515, 94-09516, 94-09518, 94-09519, 94-09520.
MANUFACTURER Medic, Inc., Knoxville, Tennessee.
RECALLED BY Manufacturer, by letters issued between August 17-21, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Tennessee, Virginia, California.
QUANTITY (a) 211 units; (b) 116 units; (c) 7 units; (d) 7 units; (e) 16
units; (f) 192 units.
REASON Blood products, incorrectly tested for the antibodies to human
immunodeficiency virus types 1 and 2 (anti-HIV-1/2), were
distributed.
PRODUCT Recovered Plasma. Recall #B-032-3.
CODE Unit #7575227.
MANUFACTURER St. Vincents Medical Center Blood Bank, Staten Island, New York.
-3-
RECALLED BY Manufacturer, by telephone February 7, 1991. Firm-initiated
recall ongoing.
DISTRIBUTION New Jersey, New York.
QUANTITY 1 unit.
REASON Blood product drawn from a high risk donor was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Red Blood Cells, Frozen. Recall #B-043-3.
CODE unit #4073261.
MANUFACTURER Department of the Navy, Naval Hospital Blood Bank, San Diego,
California.
RECALLED BY Consignee notified firm by telephone June 8, 1992.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit.
REASON Red Blood Cells, Frozen labeled with the incorrect expiration
date were distributed.
-4-
END OF ENFORCEMENT REPORT FOR NOVEMBER 4, 1992. BLANK PAGES MAY
FOLLOW.
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