Why it was recalled
Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
Product description
Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10
Lot numbers, UPCs & expiration codes
Lot #TE1Y261, Exp, 12/2013
Where it was sold
Ohio
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-1409-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 16, 2012
- FDA report date
- Jul 11, 2012
- Quantity
- 2,268 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-1409-2012, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 61871
- Address
- 650 Cathill Rd
- Code information
- Lot #TE1Y261, Exp, 12/2013
- Postal code
- 18960-1512
- Report date
- Jul 11, 2012
- Product type
- Drugs
- Recall number
- D-1409-2012
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 2,268 bottles
- Termination date
- Mar 22, 2013
- Reason for recall
- Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10
- Distribution pattern
- Ohio
- Recall initiation date
- May 16, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 5, 2012