Class II · Moderate risk
Methocarbamol Injection USP 1
Lack of Assurance of Sterility: Media fill with bacterial contamination
Methocarbamol Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Substance: Presence of hair.
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
METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged by GSMS Incorporated, Camarillo, CA 93012, USA, NDC: 60429-118-05.
Affected NDC
60429-0118-05
Compare with the code on your package — it is the most precise check available.
Drug: Methocarbamol
- Recalling firm
- Golden State Medical Supply Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1426-2015 · 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 Methocarbamol recalls
See all
Class I · High risk
Methocarbamol Injection
Presence of Particulate Matter
Class I · High risk
Methocarbamol 500mg Tablet
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Class II · Moderate risk
Methocarbamol 500mg 500
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Methocarbamol liquid 100mg/ml
Lack of sterility assurance.
Other recalls by Golden State Medical Supply Inc.
All 2015 recalls
Class II · Moderate risk
Prasugrel HCI
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Class II · Moderate risk
Carbamazepine Tablets
CGMP deviations: tablets with black specks.
Class II · Moderate risk
GSMS Incorporated
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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