Why it was recalled
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Product description
Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00
Lot numbers, UPCs & expiration codes
Lot #: 68GA, 68WE, 6A9W, 6AIT, 6ALI, 6936; Exp. 09/13 Lot #: 6BYA, 6CVI, 6FVX, 6CVH, 6D1W, 6DSH, 6E2V, 6E9W; Exp. 10/13 Lot #: 6HO2, 6I1F; Exp. 11/13 Lot #: 6IG5, 6ILV, 6HCE, 6I7B; Exp. 12/13 Lot #: 6TKA, 6TSZ, 6TUO, 6TXT; Exp. 05/14 Lot #: 6V2S, 6WWJ, 6U9L, 6UQP, 6VJM, 6VSS, 6W3J; Exp. 07/14 Lot #: 6WVP, 6XFX, 6Y99; Exp. 08/14 Lot # :6Y7A; Exp. 10/14
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-0239-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 11, 2013
- FDA report date
- Nov 12, 2014
- Quantity
- 7,740 pills
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Physicians Total Care, Inc.
Original FDA data
Every field from FDA enforcement report D-0239-2015, exactly as published.
Show all FDA fields
- City
- Tulsa
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 69595
- Address
- 12515 E 55th St Ste 106
- Code information
- Lot #: 68GA, 68WE, 6A9W, 6AIT, 6ALI, 6936; Exp. 09/13 Lot #: 6BYA, 6CVI, 6FVX, 6CVH, 6D1W, 6DSH, 6E2V, 6E9W; Exp. 10/13 Lot #: 6HO2, 6I1F; Exp. 11/13 Lot #: 6IG5, 6ILV, 6HCE, 6I7B; Exp. 12/13 Lot #: 6TKA, 6TSZ, 6TUO, 6TXT; Exp. 05/14 Lot #: 6V2S, 6WWJ, 6U9L, 6UQP, 6VJM, 6VSS, 6W3J; Exp. 07/14 Lot #: 6WVP, 6XFX, 6Y99; Exp. 08/14 Lot # :6Y7A; Exp. 10/14
- Postal code
- 74146-6234
- Report date
- Nov 12, 2014
- Product type
- Drugs
- Recall number
- D-0239-2015
- Classification
- Class III
- Recalling firm
- Physicians Total Care, Inc.
- Product quantity
- 7,740 pills
- Termination date
- Feb 4, 2015
- Reason for recall
- Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 11, 2013
- Initial firm notification
- Letter
- Center classification date
- Nov 6, 2014