Why it was recalled
Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
Product description
robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.
Lot numbers, UPCs & expiration codes
Lot #: 216702P1, Exp 09/20; 220409P1, Exp 01/21
Where it was sold
Nationwide in the USA.
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-0009-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 17, 2018
- FDA report date
- Oct 10, 2018
- Quantity
- 2,856 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Endo Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0009-2019, exactly as published.
Show all FDA fields
- City
- Malvern
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 81034
- Address
- 1400 Atwater Dr
- Code information
- Lot #: 216702P1, Exp 09/20; 220409P1, Exp 01/21
- Postal code
- 19355-8701
- Report date
- Oct 10, 2018
- Product type
- Drugs
- Recall number
- D-0009-2019
- Classification
- Class I
- Recalling firm
- Endo Pharmaceuticals, Inc.
- Product quantity
- 2,856 bottles
- Termination date
- Feb 4, 2020
- Reason for recall
- Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Sep 17, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2018