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Re: Levoxyl Recall. . . .again. . . .

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Well, I would be willing to bet, if I'd still been taking that stuff like I was up until last yr, all my bottles would have been in there of 125 mcg. Glad I'm not THERE any more. Guess I would have been even MORE dead.

Levoxyl Recall. . . .again. . . .

U.S. FOOD AND DRUG ADMINISTRATION - JULY 29, 2004http://www.fda.gov/bbs/topics/enforce/2004/ENF00858.htmlREASONStability, inability to maintain stability through labeled expiration.VOLUME OF PRODUCT IN COMMERCE992,428 bottles.DISTRIBUTIONNationwide and Puerto Rico.25 mcg, 50 mcgs, 100 mcgs, 125 mcgs 137 mcgs, 150 mcgs, 175 mcgs and 200 mcgs pills

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Posted
Posted

Well, I would be willing to bet, if I'd still been taking that stuff like I was up until last yr, all my bottles would have been in there of 125 mcg. Glad I'm not THERE any more. Guess I would have been even MORE dead.

Levoxyl Recall. . . .again. . . .

U.S. FOOD AND DRUG ADMINISTRATION - JULY 29, 2004http://www.fda.gov/bbs/topics/enforce/2004/ENF00858.htmlREASONStability, inability to maintain stability through labeled expiration.VOLUME OF PRODUCT IN COMMERCE992,428 bottles.DISTRIBUTIONNationwide and Puerto Rico.25 mcg, 50 mcgs, 100 mcgs, 125 mcgs 137 mcgs, 150 mcgs, 175 mcgs and 200 mcgs pills

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Posted
Posted

Well, I would be willing to bet, if I'd still been taking that stuff like I was up until last yr, all my bottles would have been in there of 125 mcg. Glad I'm not THERE any more. Guess I would have been even MORE dead.

Levoxyl Recall. . . .again. . . .

U.S. FOOD AND DRUG ADMINISTRATION - JULY 29, 2004http://www.fda.gov/bbs/topics/enforce/2004/ENF00858.htmlREASONStability, inability to maintain stability through labeled expiration.VOLUME OF PRODUCT IN COMMERCE992,428 bottles.DISTRIBUTIONNationwide and Puerto Rico.25 mcg, 50 mcgs, 100 mcgs, 125 mcgs 137 mcgs, 150 mcgs, 175 mcgs and 200 mcgs pills

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Posted
Posted

In a chemical sense, what does that mean? I was on Levoxyl

from the start six months ago. All of these dosages from .025 up

to .125.... I've tried.

U.S. FOOD AND DRUG ADMINISTRATION -

JULY 29, 2004

http://www.fda.gov/bbs/topics/enforce/2004/ENF00858.html

REASON

Stability, inability to maintain stability through labeled

expiration.

VOLUME OF PRODUCT IN COMMERCE

992,428 bottles.

DISTRIBUTION

Nationwide and Puerto Rico.

25 mcg, 50 mcgs, 100 mcgs, 125 mcgs 137 mcgs, 150 mcgs, 175 mcgs

and

200 mcgs pills

PRODUCT

a) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

25mcg, 100 and 1000 count bottles, Rx only,

NDC 52604-5025-1 and NDC 52604-5025-2.

Recall # D-216-4;

B) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

50mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5050-1 and NDC 52604-5050-2. Recall # D-217-4;

c) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

100mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5100-1 and NDC 52604-5100-2. Recall #

D-218-4;

d) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

125mcg, 100 count bottles, Rx only, NDC 52604-5125-1.

Recall # D-219;

e) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

137mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5137-1 and NDC 52604-5137-2. Recall # D-220-4;

f) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

150mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5150-1 and NDC 52604-5150-2. Recall #- D-221-4;

g) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

175mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5175-1 and NDC 52604-5175-2. Recall # D-222-4;

h) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

200mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5200-1 and NDC 52604-5200-2. Recall # D-223-4.

CODE

a) 100 count: Lot No. 8210, expiration 09/04 ----

1000 count: Lot No. 8211, expiration 09/04;

B) 100 count - Lot No. 8122, Exp Date 07/04; Lot No. 8125,

Exp Date 07/04; Lot No. 8127, Exp Date 07/04;

Lot No. 8129, Exp Date 07/04, Lot No. 8132, Exp Date

07/04, Lot No. 8131, Exp Date 07/04 -----

1000 count - Lot No.- Expiration: Lot No. 8124, Exp Date

07/04; Lot No. 8126, Exp Date 07/04; Lot No. 8128, Exp

Date 07/04; Lot No. 8130, Exp Date 07/04;

c) 100 count - Lot No. 8079, Exp Date 07/04, Lot No. 8136,

Exp Date 07/04 ---- 1000 count - Lot No. 8137, Exp Date

07/04; Lot No. 8138, Exp Date 07/04; Lot No. 8111,

Exp Date 07/04;

d) Lot No. 8087, Expiration 07/04;

e) 100 count - Lot No. 8105, Exp 07/04; Lot No. 8107,

Exp 07/04 ---- 1000 count - Lot No. 8104, Exp 07/04;

Lot No. 8106, Exp 07/04;

f) 100 count - Lot No. 8264, Exp 09/04; Lot No. 8266,

Exp 09/04; Lot No. 8268, Exp 10/04; Lot No. 8270,

Exp 10/04; Lot No. 8377, Exp 12/04, Lot No. 8090,

Exp 07/04; Lot No. 8092, Exp 07/04; Lot No. 8094,

Exp 07/04; Lot No. 8155, Exp 08/04; Lot No. 8156,

Exp 08/04, Lot No. 8157, Exp 08/04; Lot No. 8158,

Exp 07/04, Lot No. 8159, Exp 07/04 ----

1000 count - Lot No. 8265, Exp 09/04; Lot No. 8267,

Exp 09/04; Lot No. 8269, Exp 10/04; Lot No. 8376,

Exp 12/04; Lot. No. 8263 , Exp 09/04, Lot No. 8089,

Exp 07/04; Lot No. 8091, Exp 07/04; Lot No. 8093,

Exp 07/04;

g) 100 count - Lot No. 8121, Exp 10/04; Lot No. 8297,

Exp 10/04; Lot No. 8115, Exp 07/04; Lot No. 8116,

Exp 07/04; Lot No. 8117, Exp 07/04; Lot No. 8118,

Exp 07/04 ----- 1000 count - Lot No. 8119,

Exp 10/04; Lot No. 8120, Exp 10/04;

h) 100 count - Lot No. 8256, Exp 09/04; Lot No.8258,

Exp 09/04; Lot No. 8260, Exp 09/04; Lot No. 8096,

Exp 07/04; Lot No. 8098, Exp 07/04; Lot No. 8100,

Exp 07/04; Lot No. 8101, Exp 07/04 -----

1000 count - Lot No. 8255, Exp 09/04; Lot No. 8257,

Exp 09/04; Lot No. 8259, Exp 09/04; Lot No. 8095,

Exp 07/04; Lot No. 8097, Exp 07/04; Lot No. 8099,

Exp 07/04.

RECALLING FIRM/MANUFACTURER

King Pharmaceuticals, Inc., Bristol, TN, by letter on June 22,

2004.

Firm initiated recall is ongoing.

REASON

Stability, inability to maintain stability through labeled

expiration.

VOLUME OF PRODUCT IN COMMERCE

992,428 bottles.

DISTRIBUTION

Nationwide and Puerto Rico.

__________________________________________________

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Guest guest

Guest guest

Posted
Posted

In a chemical sense, what does that mean? I was on Levoxyl

from the start six months ago. All of these dosages from .025 up

to .125.... I've tried.

U.S. FOOD AND DRUG ADMINISTRATION -

JULY 29, 2004

http://www.fda.gov/bbs/topics/enforce/2004/ENF00858.html

REASON

Stability, inability to maintain stability through labeled

expiration.

VOLUME OF PRODUCT IN COMMERCE

992,428 bottles.

DISTRIBUTION

Nationwide and Puerto Rico.

25 mcg, 50 mcgs, 100 mcgs, 125 mcgs 137 mcgs, 150 mcgs, 175 mcgs

and

200 mcgs pills

PRODUCT

a) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

25mcg, 100 and 1000 count bottles, Rx only,

NDC 52604-5025-1 and NDC 52604-5025-2.

Recall # D-216-4;

B) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

50mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5050-1 and NDC 52604-5050-2. Recall # D-217-4;

c) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

100mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5100-1 and NDC 52604-5100-2. Recall #

D-218-4;

d) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

125mcg, 100 count bottles, Rx only, NDC 52604-5125-1.

Recall # D-219;

e) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

137mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5137-1 and NDC 52604-5137-2. Recall # D-220-4;

f) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

150mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5150-1 and NDC 52604-5150-2. Recall #- D-221-4;

g) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

175mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5175-1 and NDC 52604-5175-2. Recall # D-222-4;

h) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

200mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5200-1 and NDC 52604-5200-2. Recall # D-223-4.

CODE

a) 100 count: Lot No. 8210, expiration 09/04 ----

1000 count: Lot No. 8211, expiration 09/04;

B) 100 count - Lot No. 8122, Exp Date 07/04; Lot No. 8125,

Exp Date 07/04; Lot No. 8127, Exp Date 07/04;

Lot No. 8129, Exp Date 07/04, Lot No. 8132, Exp Date

07/04, Lot No. 8131, Exp Date 07/04 -----

1000 count - Lot No.- Expiration: Lot No. 8124, Exp Date

07/04; Lot No. 8126, Exp Date 07/04; Lot No. 8128, Exp

Date 07/04; Lot No. 8130, Exp Date 07/04;

c) 100 count - Lot No. 8079, Exp Date 07/04, Lot No. 8136,

Exp Date 07/04 ---- 1000 count - Lot No. 8137, Exp Date

07/04; Lot No. 8138, Exp Date 07/04; Lot No. 8111,

Exp Date 07/04;

d) Lot No. 8087, Expiration 07/04;

e) 100 count - Lot No. 8105, Exp 07/04; Lot No. 8107,

Exp 07/04 ---- 1000 count - Lot No. 8104, Exp 07/04;

Lot No. 8106, Exp 07/04;

f) 100 count - Lot No. 8264, Exp 09/04; Lot No. 8266,

Exp 09/04; Lot No. 8268, Exp 10/04; Lot No. 8270,

Exp 10/04; Lot No. 8377, Exp 12/04, Lot No. 8090,

Exp 07/04; Lot No. 8092, Exp 07/04; Lot No. 8094,

Exp 07/04; Lot No. 8155, Exp 08/04; Lot No. 8156,

Exp 08/04, Lot No. 8157, Exp 08/04; Lot No. 8158,

Exp 07/04, Lot No. 8159, Exp 07/04 ----

1000 count - Lot No. 8265, Exp 09/04; Lot No. 8267,

Exp 09/04; Lot No. 8269, Exp 10/04; Lot No. 8376,

Exp 12/04; Lot. No. 8263 , Exp 09/04, Lot No. 8089,

Exp 07/04; Lot No. 8091, Exp 07/04; Lot No. 8093,

Exp 07/04;

g) 100 count - Lot No. 8121, Exp 10/04; Lot No. 8297,

Exp 10/04; Lot No. 8115, Exp 07/04; Lot No. 8116,

Exp 07/04; Lot No. 8117, Exp 07/04; Lot No. 8118,

Exp 07/04 ----- 1000 count - Lot No. 8119,

Exp 10/04; Lot No. 8120, Exp 10/04;

h) 100 count - Lot No. 8256, Exp 09/04; Lot No.8258,

Exp 09/04; Lot No. 8260, Exp 09/04; Lot No. 8096,

Exp 07/04; Lot No. 8098, Exp 07/04; Lot No. 8100,

Exp 07/04; Lot No. 8101, Exp 07/04 -----

1000 count - Lot No. 8255, Exp 09/04; Lot No. 8257,

Exp 09/04; Lot No. 8259, Exp 09/04; Lot No. 8095,

Exp 07/04; Lot No. 8097, Exp 07/04; Lot No. 8099,

Exp 07/04.

RECALLING FIRM/MANUFACTURER

King Pharmaceuticals, Inc., Bristol, TN, by letter on June 22,

2004.

Firm initiated recall is ongoing.

REASON

Stability, inability to maintain stability through labeled

expiration.

VOLUME OF PRODUCT IN COMMERCE

992,428 bottles.

DISTRIBUTION

Nationwide and Puerto Rico.

__________________________________________________

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Guest guest

Guest guest

Posted
Posted

In a chemical sense, what does that mean? I was on Levoxyl

from the start six months ago. All of these dosages from .025 up

to .125.... I've tried.

U.S. FOOD AND DRUG ADMINISTRATION -

JULY 29, 2004

http://www.fda.gov/bbs/topics/enforce/2004/ENF00858.html

REASON

Stability, inability to maintain stability through labeled

expiration.

VOLUME OF PRODUCT IN COMMERCE

992,428 bottles.

DISTRIBUTION

Nationwide and Puerto Rico.

25 mcg, 50 mcgs, 100 mcgs, 125 mcgs 137 mcgs, 150 mcgs, 175 mcgs

and

200 mcgs pills

PRODUCT

a) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

25mcg, 100 and 1000 count bottles, Rx only,

NDC 52604-5025-1 and NDC 52604-5025-2.

Recall # D-216-4;

B) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

50mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5050-1 and NDC 52604-5050-2. Recall # D-217-4;

c) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

100mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5100-1 and NDC 52604-5100-2. Recall #

D-218-4;

d) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

125mcg, 100 count bottles, Rx only, NDC 52604-5125-1.

Recall # D-219;

e) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

137mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5137-1 and NDC 52604-5137-2. Recall # D-220-4;

f) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

150mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5150-1 and NDC 52604-5150-2. Recall #- D-221-4;

g) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

175mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5175-1 and NDC 52604-5175-2. Recall # D-222-4;

h) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP),

200mcg, 100 and 1000 count bottles, Rx only, NDC

52604-5200-1 and NDC 52604-5200-2. Recall # D-223-4.

CODE

a) 100 count: Lot No. 8210, expiration 09/04 ----

1000 count: Lot No. 8211, expiration 09/04;

B) 100 count - Lot No. 8122, Exp Date 07/04; Lot No. 8125,

Exp Date 07/04; Lot No. 8127, Exp Date 07/04;

Lot No. 8129, Exp Date 07/04, Lot No. 8132, Exp Date

07/04, Lot No. 8131, Exp Date 07/04 -----

1000 count - Lot No.- Expiration: Lot No. 8124, Exp Date

07/04; Lot No. 8126, Exp Date 07/04; Lot No. 8128, Exp

Date 07/04; Lot No. 8130, Exp Date 07/04;

c) 100 count - Lot No. 8079, Exp Date 07/04, Lot No. 8136,

Exp Date 07/04 ---- 1000 count - Lot No. 8137, Exp Date

07/04; Lot No. 8138, Exp Date 07/04; Lot No. 8111,

Exp Date 07/04;

d) Lot No. 8087, Expiration 07/04;

e) 100 count - Lot No. 8105, Exp 07/04; Lot No. 8107,

Exp 07/04 ---- 1000 count - Lot No. 8104, Exp 07/04;

Lot No. 8106, Exp 07/04;

f) 100 count - Lot No. 8264, Exp 09/04; Lot No. 8266,

Exp 09/04; Lot No. 8268, Exp 10/04; Lot No. 8270,

Exp 10/04; Lot No. 8377, Exp 12/04, Lot No. 8090,

Exp 07/04; Lot No. 8092, Exp 07/04; Lot No. 8094,

Exp 07/04; Lot No. 8155, Exp 08/04; Lot No. 8156,

Exp 08/04, Lot No. 8157, Exp 08/04; Lot No. 8158,

Exp 07/04, Lot No. 8159, Exp 07/04 ----

1000 count - Lot No. 8265, Exp 09/04; Lot No. 8267,

Exp 09/04; Lot No. 8269, Exp 10/04; Lot No. 8376,

Exp 12/04; Lot. No. 8263 , Exp 09/04, Lot No. 8089,

Exp 07/04; Lot No. 8091, Exp 07/04; Lot No. 8093,

Exp 07/04;

g) 100 count - Lot No. 8121, Exp 10/04; Lot No. 8297,

Exp 10/04; Lot No. 8115, Exp 07/04; Lot No. 8116,

Exp 07/04; Lot No. 8117, Exp 07/04; Lot No. 8118,

Exp 07/04 ----- 1000 count - Lot No. 8119,

Exp 10/04; Lot No. 8120, Exp 10/04;

h) 100 count - Lot No. 8256, Exp 09/04; Lot No.8258,

Exp 09/04; Lot No. 8260, Exp 09/04; Lot No. 8096,

Exp 07/04; Lot No. 8098, Exp 07/04; Lot No. 8100,

Exp 07/04; Lot No. 8101, Exp 07/04 -----

1000 count - Lot No. 8255, Exp 09/04; Lot No. 8257,

Exp 09/04; Lot No. 8259, Exp 09/04; Lot No. 8095,

Exp 07/04; Lot No. 8097, Exp 07/04; Lot No. 8099,

Exp 07/04.

RECALLING FIRM/MANUFACTURER

King Pharmaceuticals, Inc., Bristol, TN, by letter on June 22,

2004.

Firm initiated recall is ongoing.

REASON

Stability, inability to maintain stability through labeled

expiration.

VOLUME OF PRODUCT IN COMMERCE

992,428 bottles.

DISTRIBUTION

Nationwide and Puerto Rico.

__________________________________________________

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Guest guest

Guest guest

Posted
Posted

That means that these batches of Levoxyl didn't have the amts of thyroid hormone in them as was labeled on the bottles, due to whatever happened in manufacture. Thyroid hormones have a very tight range. It has to be precise.

Re: Levoxyl Recall. . . .again. . . .

In a chemical sense, what does that mean? I was on Levoxyl from the start six months ago. All of these dosages from .025 up to .125.... I've tried.

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