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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 16, 1999

Vintage Pharmaceuticals, Inc. Recalls Trifluoperazine and Fluphenazine Hydrochloride Tablets

Charlotte, NC (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Vintage Pharmaceuticals, Inc. is recalling Levothyroxine Sodium Tablets because of a lack of assurance of potency through expiration date.

PRODUCT
Levothyroxine Sodium Tablets, Rx in bottles of 100 and 1000, used as a replacement or supplemental therapy in patients with hypothyroidism and as a pituitary TSH suppressant in the treatment or prevention of various types of euthyroid goiters:
a) 25 mcg (0.025mg);
b) .50 mg (0.05mg);
c) 150 mcg (.15mg);
d) 300 mcg (.3mg).

Recall #D-256/259-9.

CODE
a) Levothyroxine Sodium 0.025mg Rx Tablets,

lot #'s:
004097A, exp. 02/99 (NDC #0254-3911-28)
004097B, exp. 02/99 (NDC #0254-3911-28)
004097C, exp. 02/99 (NDC #0603-4192-32) 047117D, exp. 05/99 (NDC #0603-4192-32)
047117E, exp. 05/99 (NDC #0254-3911-38) 047117G, exp. 05/99 (NDC #0677-1648-01)
047117H, exp. 05/99 (NDC #0677-1648-10) 032127A, exp. 05/99 (NDC #0254-3911-28)
032127B, exp. 05/99 (NDC #0254-3911-38) 032127C, exp. 05/99 (NDC #0254-4192-21)
032127D, exp. 05/99 (NDC #0603-4192-32) 033127B, exp. 05/99 (NDC #0603-4192-21)
033127C, exp. 05/99 (NDC #0603-4192-32) 033127D, exp. 05/99 (NDC #0254-3911-28)
033127E, exp. 05/99 (NDC #0254-3911-38)

b) Levothyroxine Sodium 0.05mg Rx Tablets,
lot #'s:
005097A, exp. 02/99 (NDC #0254-3912-38)
005097F, exp. 02/99 (NDC #0254-3912-38)
006097A, exp. 02/99 (NDC #0603-4193-32)
004127A, exp. 05/99 (NDC #0603-4193-21)
004127B, exp. 05/99 (NDC #0254-3912-28)
004127C, exp. 05/99 (NDC #0603-4193-32)

c) Levothyroxine Sodium 0.150mg Tablets,
lot #'s:
044087A, exp. 07/99 (NDC #0603-4196-21)
044087B, exp. 07/99 (NDC #0254-3915-28)
044087C, exp. 07/99 (NDC #0677-0992-01)
044087D, exp. 07/99 (NDC #0254-3915-38)
044087E, exp. 07/99 (NDC #0603-4196-32)

d) Levothyroxine Sodium 0.3mg Rx Tablets,
lot #'s:
017047C, exp. 03/99 (NDC #0254-3917-28)
017047D, exp. 03/99 (NDC #0254-3917-28)
017047F, exp. 03/99 (NDC #0254-3917-28)
017047G, exp. 03/99 (NDC #0603-4198-21)
017047B, exp. 03/99 (NDC #0603-3917-38)

MANUFACTURER
Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.

RECALLED BY
Manufacturer, by letter dated November 11, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama.

QUANTITY
4800 bottles of Levothyroxine Sodium 0.025mg, lot #004097A.
6077 bottles of Levothyroxine Sodium 0.025mg, lot #004097B.
954 bottles of Levothyroxine Sodium 0.025mg, lot #004097C.
532 bottles of Levothyroxine Sodium 0.025mg, lot #047117D.
1369 bottles of Levothyroxine Sodium 0.025mg, lot #047117E.
1421 bottles of Levothyroxine Sodium 0.025mg, lot #047117G.
838 bottles of Levothyroxine Sodium 0.025mg, lot #047117H.
4192 bottles of Levothyroxine Sodium 0.025mg, lot #032127A.
1208 bottles of Levothyroxine Sodium 0.025mg, lot #032127B.
2772 bottles of Levothyroxine Sodium 0.025mg, lot #032127C.
984 bottles of Levothyroxine Sodium 0.025mg, lot #032127D.
2592 bottles of Levothyroxine Sodium 0.025mg, lot #033127B.
1800 bottles of Levothyroxine Sodium 0.025mg, lot #033127C.
2527 bottles of Levothyroxine Sodium 0.025mg, lot #033127D.
600 bottles of Levothyroxine Sodium 0.025mg, lot #033127E.
1179 bottles of Levothyroxine Sodium 0.05mg, lot #005097A.
804 bottles of Levothyroxine Sodium 0.05mg, lot #005097F.
3000 bottles of Levothyroxine Sodium 0.05mg, lot #006097A.
3192 bottles of Levothyroxine Sodium 0.05mg, lot #004127A.
9720 bottles of Levothyroxine Sodium 0.05mg, lot #004127B.
1074 bottles of Levothyroxine Sodium 0.05mg, lot #004127C.
652 bottles of Levothyroxine Sodium 0.3mg, lot

#017047C.
1792 bottles of Levothyroxine Sodium 0.3mg, lot #017047D.
1440 bottles of Levothyroxine Sodium 0.3mg, lot #017047F.
1200 bottles of Levothyroxine Sodium 0.3mg, lot #017047G.
924 bottles of Levothyroxine Sodium 0.3mg, lot

#017047B.
1407 bottles of Levothyroxine Sodium 0.150mg lot #044087A.
1784 bottles of Levothyroxine Sodium 0.150mg lot #044087B.
1195 bottles of Levothyroxine Sodium 0.150mg lot #044087C.
829 bottles of Levothyroxine Sodium 0.150mg lot #044087D.
589 bottles of Levothyroxine Sodium 0.150mg lot #044087E.

 

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.