Why it was recalled
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Product description
Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6.
Lot numbers, UPCs & expiration codes
Lot #: 3122856, Exp 05/14
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-346-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 22, 2013
- FDA report date
- Dec 18, 2013
- Quantity
- 4896 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-346-2014, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 66065
- Address
- 111 S Calvert St Fl 21st
- Code information
- Lot #: 3122856, Exp 05/14
- Postal code
- 21202-6174
- Report date
- Dec 18, 2013
- Product type
- Drugs
- Recall number
- D-346-2014
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 4896 bottles
- Termination date
- Dec 30, 2013
- Reason for recall
- Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 22, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 12, 2013