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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
December 16, 1998

PRODUCT
a) Levothyroxine Sodium, USP, Tablets, 25 mcg (0.025 mg), Rx in 100 tablet bottles; b) Levothyroxine Sodium, USP, Tablets, 75 mcg (0.075 mg), Rx in 100 and 1,000 tablet bottles; c) Lexothyroxine Sodium, USP Tablets, 150 mcg (0.15 mg), in 100 and 1,000 tablet bottles. Levothyroxine Sodium Tablets are 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; d) Belladonna Alkaloids with Phenobarbital Tablets (Hyoscyamine Sulfate, USP 0.1037 mg/Atropine Sulfate, USP 0.0194 mg/Scolopamine Hbr 0.085 mg/Phenobarbital, USP 16.2 mg) in 100 and 1,000 tablet bottles; e) Phenobarbital, USP Tablets, 16.2 mg (1/4 gr) in 100 and 1,000 tablet bottles, used as sedatives and anticonvulsant for the treatment of generalized and partial seizures. Recall #D-024/028-9.

CODE

a) Levothyroxine Sodium 0.025mg Rx Tablets, lot #'s:
036077C, exp. 12/98 (NDC #0603-4192-21)
036077D, exp. 12/98 (NDC #0254-3911-28)
b) Levothyroxine Sodium 0.15mg Rx Tablets, lot #'s:
018047A, EXP 03/98 (NDC #0254-3915-28)
018047B, EXP 03/98 (NDC #0603-4196-32)
018047C, EXP 03/98 (NDC #0254-3915-38)
c) Levothyroxine Sodium 0.075mg Rx Tablets, lot #'s:
008096A, EXP 10/98 (NDC #0603-4194-32)
008096B, EXP 10/98 (NDC #0254-3913-38)
008096C, EXP 10/98 (NDC #0254-3913-28)
008096D, EXP 10/98 (NDC #0254-3913-28)
d) Phenobarbital/Belladonna Alkaloids Rx Tablets, lot #'s:
039116B, exp. 10/98 (NDC #0254-2320-38)
039116C, exp. 10/98 (NDC #0603-2418-21)
e) Phenobarbital USP 16.2mg (1/4gr) Rx Tablets, lot #'s:
077058B, EXP 06/00 (NDC #0254-5011-28)
077058D, EXP 06/00 (NDC #0254-5011-38).

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

RECALLED BY
Manufacturer, by letters dated August 14, 1998, and September 18, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama.

QUANTITY

1,872 bottles of Levothyroxine Sodium 0.025mg Rx Tablets, lot
#036077C.
2,080 bottles of Levothyroxine Sodium 0.025mg Rx Tablets, lot
#036077D.
1,584 bottles of Levothyroxine Sodium 0.075mg Rx Tablets, lot
#008096A.
724 bottles of Levothyroxine Sodium 0.075mg Rx Tablets, lot
#008096B.
1,171 bottles of Levothyroxine Sodium 0.075mg Rx Tablets, lot
#008096C.
3,599 bottles of Levothyroxine Sodium 0.075mg Rx Tablets, lot
#008096D.
1,301 bottles of Levothyroxine Sodium 0.15mg Rx Tablets, lot
#018047A.
1,711 bottles of Levothyroxine Sodium 0.15mg Rx Tablets, lot
#018047B.
992 bottles of Levothyroxine Sodium 0.15mg Rx Tablets, lot
#018047C.
894 bottles of Phenobarbital/Belladonna Alkaloids Rx Tablets, lot
#039116B.
1,436 bottles of Phenobarbital/Belladonna Alkaloids Rx Tablets,
lot #039116C.
4,121 bottles of Oxycodone/Acetaminophen, USP 5/500mg Rx
Capsules, lot #049097A.
3,591 bottles of Phenobarbital USP 16.2mg (1/4gr) Rx Tablets, lot
#077058B.
2,167 bottles of Phenobarbital USP 16.2mg (1/4gr) Rx Tablets, lot
#077058D.

REASON
a-d) Inability to assure potency throughout expiration date. e) Possibility of cross contamination.

 

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.