Hydrocodone Bitartrate and Acetaminophen Oral Solution recall: CGMP Deviations
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b)…
Why was Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled?
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
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?
a). Lot No. 419000 (Exp. 03/17) b.) Lot No. 419800 (Exp. 03/17), 429100 (Exp. 06/17) c). Lot No. 418200 (Exp. 03/17), 430100 (Exp. 06/17), 423800 (Exp. 04/17), 413100 (Exp. 02/17), 410700 (Exp. 01/17)
- Product
- Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b)…
- Recalling firm
- VistaPharm, Inc.
- Quantity
- 32,027 bottles and 16,310 unit dose cups
- Distribution
- Nationwide
- Recall date
- February 8, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)