Class II · Moderate risk Terminated
Carisoprodol Tablets
Reason Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Carisoprodol Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurity/degradation Specification
What was recalled
Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- NDC code
- 51079-819-20
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1155-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Carisoprodol recalls
See all
Class II · Moderate risk Terminated
Carisoprodol IV
Reason Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Class II · Moderate risk Terminated
Carisoprodol Tablets
Reason Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Class II · Moderate risk Terminated
Carisoprodol Tablets
Reason Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Class III · Low risk Terminated
Carisoprodol Tablets
Reason Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.
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