Why it was recalled
Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.
Product description
Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2.
Lot numbers, UPCs & expiration codes
Lot # 11338, Exp 04/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1673-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 20, 2012
- FDA report date
- Sep 12, 2012
- Quantity
- 12,720 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medtech Products, Inc.
Original FDA data
Every field from FDA enforcement report D-1673-2012, exactly as published.
Show all FDA fields
- City
- Irvington
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 62402
- Address
- 90 North Broadway
- Code information
- Lot # 11338, Exp 04/13
- Postal code
- 10533
- Report date
- Sep 12, 2012
- Product type
- Drugs
- Recall number
- D-1673-2012
- Classification
- Class II
- Recalling firm
- Medtech Products, Inc.
- Product quantity
- 12,720 bottles
- Termination date
- Apr 11, 2017
- Reason for recall
- Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 20, 2012
- Initial firm notification
- Letter
- Center classification date
- Sep 6, 2012