Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Lipitor (Atorvastatin calcium)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0
Affected NDC
54868-4229-00
Compare with the code on your package — it is the most precise check available.
Drug: Atorvastatin Category: Cholesterol Medication
- Recalling firm
- Physicians Total Care, Inc.
- NDC code
- 54868-4229-0
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1389-2012 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Atorvastatin recalls
See all
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 40 mg
Failed dissolution specifications: lower than specifications
Other recalls by Physicians Total Care, Inc.
All 2012 recalls
Class II · Moderate risk
Cephalexin Monohydrate Capsules
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Class II · Moderate risk
Carisoprodol IV
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Class III · Low risk
Loratadine 24 HR-OTC
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Class II · Moderate risk
Belladonna Alkaloids/PB
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.