Class II · Moderate risk
Cephalexin Monohydrate Capsules
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Plavix 75 mg
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).
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
Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146.
Affected NDC
54868-4070-00
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Physicians Total Care, Inc.
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-317-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Physicians Total Care, Inc.
All 2011 recalls
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.
Other chemical / undeclared recalls from 2011
All chemical / undeclared recalls
Class I · High risk
Actra-SX 500 Capsules
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Class III · Low risk
Earth Force
Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover).
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