FOOD AND DRUG
ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
February 24, 1999PRODUCT
a) TAC-3 Injectable Suspension,(Triamcinolone Acetonide),
3 mg/mL, Rx in 5 mL vials, (Parnell)
NDC 0023-0218-05 (Allergan Pharmaceuticals)
NDC 50930-218-05 (Parnell Pharmaceuticals);
b) Triamcinolone Acetonide Injectable Suspension, USP, 40 mg/mL ,
Rx in 5 mL and 1mL vials,
NDC 0402-0204-05 (Steris Laboratories)
NDC 0364-6728-53 (Schein Pharmaceuticals)
NDC 0456-0781-05 (Forest Pharmaceuticals)
NDC 66467-9810-8 (Darby (Carlisle))
NDC 0182-1141-62 (Zenith Goldline Laboratories)
DIN# 02219271 (Schein Canada)
NDC 0677-0600-20 (United Research Laboratories)
NDC 55553-204-05 (Clint Pharmaceuticals)
NDC 25332-0101-2 (Legere Pharmaceuticals)
NDC 0536-9810-65 (Rugby Laboratories)
NDC 0839-6287-25 (Moore Medical)
NDC 53614-204-05 (Besse Medical)
NDC 52637-040-05 (AF Hauser)
NDC 11001-204-05 (San Jose Surgical Supply)
NDC 54171-204-05 (Robar)
NDC 52384-006-05 (Teregen Labs)
NDC 0904-0886-05 (Major Pharmaceutical)
NDC 0402-0204-01 (Steris Laboratories)
NDC 0364-6728-46 (Schein Pharmaceuticals)
NDC 0182-1141-85 (Zenith Goldline Laboratories)
DIN# 02219271 (Schein Canada)
NDC 99012-204-01 (RW Enterprises);
c) Prednisolone Acetate Injectable Suspension, USP, (sterile), 50
mg/mL in 10 mL and 30 mL vials, Rx,
NDC 0402-0249-30 (Steris Laboratories)
NDC 0364-6627-56 (Schein Pharmaceutical)
NDC 66467-6405-3 (Darby Group (Carlisle)
NDC 0182-0939-66 (Zenith Goldline Laboratories)
NDC 0402-0249-10 (Steris)
NDC 0364-6627-54 (Schein Pharmaceutical)
NDC 0456-0924-10 (Forest Pharmaceuticals);
d) Hydrocortisone Acetate Injectable Suspension,(sterile), 25
mg/mL, Rx in 10 mL vials
NDC 0402-0051-10 (Steris Laboratories)
NDC 0364-6624-54 (Schein Laboratories)
NDC 0067-0278-21 (United Research Laboratories)
NDC 66467-1200-1 (Darby (Carlisle);
e) Estrone Injectable Suspension, USP, (sterile) 5 mg/mL, Rx in
10 mL bottles
NDC 0402-0041-10 (Steris Laboratories)
NDC 0364-6601-54 (Schein Pharmaceutical)
NDC 57699-041-10 (A &G Pharmaceutical)
NDC 0677-0274-21 (United Research Laboratories)
NDC 0839-5585-30 (Moore Medical)
NDC 66467-5602-1 (Darby (Carlisle)
NDC 55553-041-10 (Clint Pharmaceuticals)
NDC 0314-0644-70 (Hyrex Pharmaceuticals)
f) Dalalone D.P. Injectable Suspension (Dexamethasone Acetate
Suspension), 16 mg/mL, Rx in 1 mL vials, NDC 0456-1097-41
(Forest Pharmaceuticals). Recall #D-100/105-9.
CODE
Lot numbers: a) 96B600 and 97E500; b) 96M880, 96N020, 98A331,
98B271, 98B701, 98C200, 98C371, 98C560, 98C721, 98D091, 98D210,
98D310, 98D470, 97D830, 97D831, 97J340, 97K670, 97F830, 97K160;
c) 96B670, 96E260, 96L540, 96M640, 96M630; d) 96C120, 96L140,
96N540; e) 96C040, 96E730, 96H400, 97A990, 97D610, 97E980, 97K990
f)97B740.
MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona
RECALLED BY
Manufacturer, by letter on December 10, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Dexamethasone Acetate Suspension, 16 mg/mL, 1ml
37,400 - Distributed
Estrone Suspension, 5 mg/mL, 10ml
250,161 - Distributed
Hydrocortisone Acetate Suspension, 25mg/mL, 10ml
47,976 - Distributed
Prednisolone Acetate Suspension, 50 mg/mL, 10ml
16,984 - Distributed
Prednisolone Acetate Suspension, 50 mg/mL, 30ml
48,588 - Distributed
Triamcinolone Acetonide Suspension, 40 mg/mL, 1 mL
465,557 - Distributed
Triamcinolone Acetonide Suspension, 40 mg/mL, 5 mL
700,646 - Distributed
Triamcinolone Acetonide Suspension, 3 mg/mL, 5 mL
39,634 - Distributed.
REASON
Products lack valid resuspendability data. |
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