Recalls / Class III
Class IIID-0239-2015
Product
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
- Affected lot / code info
- 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
Why it was recalled
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Recalling firm
- Firm
- Physicians Total Care, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 12515 E 55th St Ste 106, N/A, Tulsa, Oklahoma 74146-6234
Distribution
- Quantity
- 7,740 pills
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-09-11
- FDA classified
- 2014-11-06
- Posted by FDA
- 2014-11-12
- Terminated
- 2015-02-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0239-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.