CLASS II Drug recall · Reported 4 Jul 2012 · FDA Enforcement Report
Methylprednisolone Tablets, USP, 4 mg recalled by Physicians Total Care
Physicians Total Care is recalling Methylprednisolone Tablets, USP, 4 mg per, distributed in Georgia, Pennsylvania. The recall was initiated on 18 Mar 2011 and the FDA has classified it as Class II.
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-1391-2012
- FDA event ID
- 62122
- Recalling firm
- Physicians Total Care, Tulsa, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Mar 2011
- FDA classified
- 22 Jun 2012
- Reported
- 4 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- FAX
- Reason category
- Potency & Assay
Timeline
| 18 Mar 2011 | Recall initiated by company | |
| 22 Jun 2012 | Classified by FDA | +462 days |
| 4 Jul 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by: Physicians Total Care Inc., Tulsa, OK 74146, NDC # 54868-2913-03
Where it was distributed
GA, PA
Questions about this recall
Is Methylprednisolone Tablets, USP, 4 mg per recalled?
Yes. Physicians Total Care recalled Methylprednisolone Tablets, USP, 4 mg per on 18 Mar 2011. The recall is Class II and its status is Terminated. Recall number D-1391-2012.
Why was it recalled?
Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life
Which lots are affected?
Lot # 5ASX, Exp 10/31/2011; 5O37; 5QSQ; 5T6J; 5U7Z; 5WIC; 5XDS; 5ZHY; 601J; 63MJ; 64O0, Exp. 02/28/2012.
Where was it sold?
GA, PA
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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 III | Loratadine 24 HR recalled by Physicians Total Care | Physicians Total Care | Other | Nationwide |
| 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 |
Other Methylprednisolone recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | methylprednisolone tablets, USP Dosepak, 4 mg recalled by GreenstoneMethylprednisolone | Greenstone | Other | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Methylprednisolone acetate Injectable Suspension recalled by Eugia USMethylprednisolone Acetate | Eugia US | Potency & Assay | 4 states |
| Drug | CLASS II | Depo-Medrol (methylprednisolone acetate injectable recalledDepo-medrol | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Depo-Medrol (methylprednisolone acetate injectable recalledDepo-medrol | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |