Hydrocodone Bitartrate & Acetaminophen Oral Solution recall: Impurity Out of Spec
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles…
Why was Hydrocodone Bitartrate & Acetaminophen Oral Solution recalled?
Impurities/Degradation Products: exceeded specification at 3 month 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 #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13.
- Product
- Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles…
- Recalling firm
- VistaPharm, Inc.
- Quantity
- a) 949 Cases, b) 188 bottles
- Distribution
- Nationwide
- Recall date
- July 18, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)