Northstar Zolpidem Tartrate Tablets Recalled for Foreign Valacyclovir Contamination
Aurobindo Pharma is recalling Northstar Zolpidem Tartrate Tablets 10 mg because 30 valacyclovir tablets were found in a bottle.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of a different medication (valacyclovir) in a zolpidem bottle poses a significant risk of incorrect dosing and potential serious injury.
Plain-English summary
Aurobindo Pharma Limited is recalling Northstar Zolpidem Tartrate Tablets USP 10 mg. The recall is due to the discovery of 30 valacyclovir hydrochloride tablets USP 500 mg inside a bottle labeled as Zolpidem Tartrate tablets.
The affected product was manufactured for Northstar RX, LLC in Memphis, TN, and manufactured by Aurobindo Pharma Limited in India. The recall covers 23,616 bottles with Batch Number ZPSB11054-A and an expiration date of 05/13. The product was distributed nationwide.
Consumers should check their medication for this specific batch number and expiration date. If they have the affected product, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- 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
- Manufacturer
- Aurobindo Pharma LTD
- Category
- Drug — Prescription Medication
- Affected units
- 23,616
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch Number ZPSB11054-A Exp. 05/13
Distribution
Distributed nationwide across the United States.
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