Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16…

Is this the product you have?

• • Nystatin Oral Suspension
  • USP 100
  • 000 units per mL
  • a) 2 fl. oz. (60 mL)
  • 24 bottles per case (NDC 66689-008-02)
  • b) 16 fl. oz. (237 mL)
  • 12 bottles per case (NDC 66689-008-16)
  • Rx only
  • Manufactured by VistaPharm
  • Largo
  • FL 33771

Lot codes and dates

• a) Lot No. 422600 (Exp. 10/17), 420000 (Exp. 09/17), 416100 (Exp. 08/17), 417400 (Exp. 09/17) b) Lot No. 424200 (Exp. 10/17), 415500 (Exp. 03/18)

Amount recalled

67,955 bottles

This recall covers 11 products

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

• 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…
• Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5…
• 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.