Why it was recalled
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Product description
Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104
Lot numbers, UPCs & expiration codes
Batch Numbers: (a) 2544488, Exp 7/31/2016; 26917891, Exp 5/31/2016. (b) 2544488, Exp 7/31/2016; 2617893, Exp 5/31/2016; 2644273, 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-0037-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 28, 2015
- FDA report date
- Oct 21, 2015
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ohm Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0037-2016, 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) 2544488, Exp 7/31/2016; 26917891, Exp 5/31/2016. (b) 2544488, Exp 7/31/2016; 2617893, Exp 5/31/2016; 2644273, Exp 9/30/2016
- Postal code
- 08902-1829
- Report date
- Oct 21, 2015
- Product type
- Drugs
- Recall number
- D-0037-2016
- Classification
- Class III
- Recalling firm
- Ohm Laboratories, Inc.
- Termination date
- Oct 28, 2016
- Reason for recall
- Superpotent Drug: Out Of Specification (OOS) result for Assay.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jul 28, 2015
- Initial firm notification
- Letter
- Center classification date
- Oct 15, 2015