Why it was recalled
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Product description
Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand)
Lot numbers, UPCs & expiration codes
Lot #: 2625094, Exp 06/2016
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-1142-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 4, 2015
- FDA report date
- Jun 24, 2015
- Quantity
- 2592 Blister Packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ohm Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1142-2015, exactly as published.
Show all FDA fields
- City
- North Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71334
- Address
- 1385 Livingston Ave
- Code information
- Lot #: 2625094, Exp 06/2016
- Postal code
- 08902-1829
- Report date
- Jun 24, 2015
- Product type
- Drugs
- Recall number
- D-1142-2015
- Classification
- Class III
- Recalling firm
- Ohm Laboratories, Inc.
- Product quantity
- 2592 Blister Packs
- Termination date
- Aug 15, 2016
- Reason for recall
- Superpotent Drug: Out Of Specification (OOS) result for Assay.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand)
- Distribution pattern
- Nationwide
- Recall initiation date
- May 4, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 18, 2015