why was Senokot S taken off the the shelves at pharmacies, and will it
be brought back

Hello basilbt,  
 

Purdue Frederic recalled Senokot-S Tablets because of mislabeling. 
The labeling does not indicate dosage instructions for children under
2 years of age.


Below is The Food and Drug Administration (FDA) Enforcement Report
where you may verify that this is the correct answer.

“The FDA Enforcement Report is published weekly by the Food and Drug
Administration, Department of Health and Human Services. It contains
information on actions taken in connection with agency Regulatory
activities.”

FDA Enforcement Report May 21, 2003

 “Senokot-S Tablets (Docusate sodium 50mg and Sennosides 8.6mg)
Natural Vegetable Laxative plus Softener, Standardized Senna
Concentrate and Docusate Sodium, blisterpack of 4 tablets,
Professional Samples: Not for Sale. Recall # D-224-3.”

CODE
Lot JV31, Exp. 01/04;
Lot JV41, Exp. 01/04;
Lot MA11, Exp. 06/04.

RECALLING FIRM/MANUFACTURER
“The Purdue Frederick Company, Stamford, CT, via voicemail on March
11, 2003, and follow-up letter on March 21, 2003. Firm initiated
recall is ongoing.”

REASON: “Mislabeled; Labeling does not indicate dosage instructions
for children under 2 years of age.”

VOLUME OF PRODUCT IN COMMERCE: 924,279

DISTRIBUTION: Nationwide

Source: 
FDA Enforcement Report
May 21, 2003
http://www.fda.gov/bbs/topics/enforce/2003/ENF00796.html


At SafetyAlerts you may search for recalls as well.

“SafetyAlerts has 16 main categories that are updated daily.  Food,
Toys, Drugs & Medicine, Clothing, Furniture, Child/Infant, Child Car
Seats, Vitamins, Autos, Sports, Outdoor items, Appliances,
Cosmetics/Hygiene, Electronics and Household items and Food Allergy.”
http://www.safetyalerts.com/


SafetyAlerts
May 21, 2003
Purdue Frederic Has Recalled Senokot-S Tablets
REASON: Mislabeled; Labeling does not indicate dosage instructions for
children under 2 years of age.
DISTRIBUTION: Nationwide
Source: SAfetyAlerts
http://www.safetyalerts.com/recall/f/02.2/f0002640.htm

  
You may sign-up for SafetyAlerts by Email here:
http://www.safetyalerts.com/sub/asub1.htm



Additional information that may interest you:


The June 4, 2003 FDA Enforcement Report states that Senokot granules
are being recalled for mold contamination.

PRODUCT: Senokot Granules (standardized senna concentrate), Natural
Vegetable Laxative, 15mg sennosides in each teaspoon, 6 oz and 12 oz
bottles. Recall # D-262-3.

REASON: “Mold contamination-Inactive ingredient-Malt syrup lot used in
granule manufacturing had expired and was later found to contain
surface mold.”
You may read the complete report at the FDA website at this direct
linkk:
http://www.fda.gov/bbs/topics/Enforce/2003/ENF00798.html


Search Criteria:

Senokot S
site:www.fda.gov Senokot S
Senokot S Recall


I hope this helps. If anything is unclear or if a link does not
function please let me know and I'll be glad to offer further
assistance.


Best Regards,
Bobbie7-ga

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Request for Answer Clarification by basilbt-ga on 28 Jul 2003 21:37 PDT

I also asked when it would be put back on the shelves in pharmacie-if
possible I would like an answer

---

Clarification of Answer by bobbie7-ga on 28 Jul 2003 22:12 PDT

Dear Basilbt,

I apologize for not mentioning that presently there is no information
available yet online as this recall was very recent.

I just sent out an email inquiry to Purdue Pharma asking if Senokot-S
Tablets will be put back in circulation again.

As soon as I receive a reply I will let you know.

Thank you for your patience.

Sincerely,
Bobbie7

---

Clarification of Answer by bobbie7-ga on 29 Jul 2003 08:04 PDT

Basilbt,

I got in touch with the Senokot Comfort Line  at 800.726.4280 and they
said that there’s no confirmed date yet and it may take as long as a
year to put the product back on the store shelves.

I hope this helps!

Best regards,
Bobbie7

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Request for Answer Clarification by basilbt-ga on 07 Aug 2003 21:41 PDT

Today I asked a pharmacist why Senokot S was taken off the market, and
he said that it contained an ingredient that was harmful.  When I
received my answer from Google, there was no mention of this problem. 
Could you clarify this for me.   I do not feel my question has been
answered correctly.

---

Clarification of Answer by bobbie7-ga on 07 Aug 2003 22:17 PDT

The only authoritative source for this kind of information is the Food
and Drug Administration (FDA) Enforcement Report.

“The FDA Enforcement Report is published weekly by the Food and Drug
Administration, Department of Health and Human Services. It contains
information on actions taken in connection with agency Regulatory
activities.”

As I mentioned previously, the reason for the recall according to the
FDA is:

REASON: “Mislabeled; Labeling does not indicate dosage instructions
for children under 2 years of age.”
http://www.fda.gov/bbs/topics/enforce/2003/ENF00796.html 


I have personal experience with several pharmacists in my family who
assure me that rumors fly in these situations. You are free to believe
your pharmacist over the official statement of the FDA who forced the
recall in the first place.

Your question has been answered correctly by the most authoritative
source, the Food and Drug Administration.

In any case you may ask for a refund if the official answer from the
FDA Enforcement Report doesn’t suit you.
https://answers.google.com/answers/main?cmd=refundrequest