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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
February 24, 1999

PRODUCT
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.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.