Recalls / Class II
Class IID-0937-2017
Product
Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Affected lot / code info
- Lots: MCMR1308029NS, MCMR1308029NS-4202015; Exp. 08/18
Why it was recalled
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Recalling firm
- Firm
- American Pharmaceutical Ingredients LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 6650 Highland Rd Ste 302, N/A, Waterford, Michigan 48327-1665
Distribution
- Quantity
- 5,000g (5 kg)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-05-26
- FDA classified
- 2017-07-02
- Posted by FDA
- 2017-07-12
- Terminated
- 2018-05-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0937-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.