CLASS III Drug recall · Reported 12 Nov 2014 · FDA Enforcement Report
Loratadine 24 HR recalled by Physicians Total Care
Physicians Total Care is recalling Loratadine 24 HR, distributed nationwide in the US. The recall was initiated on 11 Sep 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0239-2015
- FDA event ID
- 69595
- Recalling firm
- Physicians Total Care, Tulsa, OK
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Sep 2013
- FDA classified
- 6 Nov 2014
- Reported
- 12 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Allergy Medication
Timeline
| 11 Sep 2013 | Recall initiated by company | |
| 6 Nov 2014 | Classified by FDA | +421 days |
| 12 Nov 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Which lots are affected?
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 was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Physicians Total Care
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cephalexin Monohydrate Capsules,USP, 500 mg recalled | Physicians Total Care | Manufacturing (CGMP) Deviations | GA, MO |
| Drug | CLASS II | Carisoprodol IV ( Carisoprodol Tablets USP) 350mg recalled | Physicians Total Care | Lead & Heavy Metals | 4 states |
| Drug | CLASS II | Belladonna Alkaloids/PB (Belladonna Alkaloids recalled | Physicians Total Care | Packaging Defects | GA |
| Drug | CLASS III | Voltaren 1% Gel, 100 gm tube recalled by Physicians Total Care | Physicians Total Care | Other | Nationwide |
| Drug | CLASS II | Metronidazole Tablets, USP, 500 mg recalled by Physicians Total Care | Physicians Total Care | Packaging Defects | Nationwide |