Class III · Low risk
Carisoprodol Tablets
Failed Impurity/degradation Specification
Carisoprodol Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.
Affected NDC
0591-5513-05
Compare with the code on your package — it is the most precise check available.
Drug: Carisoprodol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Carisoprodol NDC 00591-5513 |
350 mg/1 | Tablet | Actavis Pharma, Inc. | DRUG FOR FURTHER PROCESSING · CIV |
- Recalling firm
- Watson Laboratories Inc
- NDC code
- 0591-5513-05
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-397-2014 · 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 Carisoprodol recalls
See all
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 II · Moderate risk
Carisoprodol Tablets
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
Carisoprodol Tablets
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Class III · Low risk
Carisoprodol Tablets
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.
Other recalls by Watson Laboratories Inc
All 2013 recalls
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets USP
Failed Tablet/Capsule Specifications; Product contains broken tablets.
Class II · Moderate risk
Next Choice" One Dose Emergency Contraceptive
Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.
Class II · Moderate risk
Oxycodone and Acetaminophen Tablets
Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.
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