Why it was recalled
Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
Product description
Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India
Lot numbers, UPCs & expiration codes
Batch Number ZPSB11054-A Exp. 05/13
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-041-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 9, 2012
- FDA report date
- Nov 14, 2012
- Quantity
- 23,616 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma LTD
Original FDA data
Every field from FDA enforcement report D-041-2013, exactly as published.
Show all FDA fields
- City
- Mehbubnagar
- Status
- Terminated
- Country
- India
- Event ID
- 62113
- Address
- Unit VII, Formulation Plant
- Address (line 2)
- Survey 411, 425, 434-435, 458, Plot S1
- Code information
- Batch Number ZPSB11054-A Exp. 05/13
- Report date
- Nov 14, 2012
- Product type
- Drugs
- Recall number
- D-041-2013
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma LTD
- Product quantity
- 23,616 bottles
- Termination date
- Nov 21, 2013
- Reason for recall
- Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 9, 2012
- Initial firm notification
- FAX
- Center classification date
- Nov 6, 2012