Dextroamphetamine Sulfate Tablets recall: Impurity Out of Spec
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
Why was Dextroamphetamine Sulfate Tablets recalled?
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 34013122A, Exp 11/15
- Product
- Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 9,882 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- July 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)