Why it was recalled
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Product description
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
Lot numbers, UPCs & expiration codes
Lots: MCMR1308029NS, MCMR1308029NS-4202015; Exp. 08/18
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0937-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 26, 2017
- FDA report date
- Jul 12, 2017
- Quantity
- 5,000g (5 kg)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Pharmaceutical Ingredients LLC
Original FDA data
Every field from FDA enforcement report D-0937-2017, exactly as published.
Show all FDA fields
- City
- Waterford
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 77392
- Address
- 6650 Highland Rd Ste 302
- Code information
- Lots: MCMR1308029NS, MCMR1308029NS-4202015; Exp. 08/18
- Postal code
- 48327-1665
- Report date
- Jul 12, 2017
- Product type
- Drugs
- Recall number
- D-0937-2017
- Classification
- Class II
- Recalling firm
- American Pharmaceutical Ingredients LLC
- Product quantity
- 5,000g (5 kg)
- Termination date
- May 31, 2018
- Reason for recall
- CGMP Deviations: Lack of quality assurance at the API manufacturer.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- May 26, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 2, 2017