Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No.…

Is this the product you have?

• Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.

Lot codes and dates

• a). Lot No. 427900, 426700 (Exp. 11/17), 424800, 423600 (Exp. 10/17), 420800 (09/17), 416300 (08/17), 407700, 407300 (Exp. 06/17), 405900, 403900 (Exp. 05/17) b). Lot No. 426900 (Exp. 11/17), 404700 (Exp. 05/17), 390200 (Exp. 02/17)

Amount recalled

42,776 unit dose cups and 17,403 bottles

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

• Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles…
• Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II…
• Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx…
• Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx…
• Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per…
• Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only…
• Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only…
• Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12…
• Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000…
• Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per…

Where it was sold

• Nationwide

Why it was recalled

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

This product could cause temporary or reversible health problems — stop using it.