Why it was recalled
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Product description
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.
Lot numbers, UPCs & expiration codes
Batch Numbers: a) 2600127, Exp 2/29/2016; 2617892, Exp 5/31/2016; 2644265, 9/30/2016; 2625092, Exp, 6/30/2016; 2658140, Exp 11/30/2016. b) 2617892, Exp 5/31/2016; 2610783, 4/30/2016; 2644272, Exp 9/30/2016
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-0035-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 28, 2015
- FDA report date
- Oct 21, 2015
- Quantity
- 53,688 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ohm Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0035-2016, exactly as published.
Show all FDA fields
- City
- North Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71973
- Address
- 1385 Livingston Ave
- Code information
- Batch Numbers: a) 2600127, Exp 2/29/2016; 2617892, Exp 5/31/2016; 2644265, 9/30/2016; 2625092, Exp, 6/30/2016; 2658140, Exp 11/30/2016. b) 2617892, Exp 5/31/2016; 2610783, 4/30/2016; 2644272, Exp 9/30/2016
- Postal code
- 08902-1829
- Report date
- Oct 21, 2015
- Product type
- Drugs
- Recall number
- D-0035-2016
- Classification
- Class III
- Recalling firm
- Ohm Laboratories, Inc.
- Product quantity
- 53,688 boxes
- Termination date
- Oct 28, 2016
- Reason for recall
- Superpotent Drug: Out Of Specification (OOS) result for Assay.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jul 28, 2015
- Initial firm notification
- Letter
- Center classification date
- Oct 15, 2015