The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0463-2017·Announced 2017-02-08

VistaPharm Recalls Lactulose Solution Due to Potential Bacterial Contamination

VistaPharm is recalling Lactulose Solution USP because purified water used in manufacturing may have been contaminated with Burkholderia cepacia.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for potential serious adverse health consequences.

Plain-English summary

VistaPharm, Inc. is recalling Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case (NDC No. 66689-039-50). The recall involves 7,404 unit dose cups distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Affected lots include Lot No. 728300 (Exp. 11/17), 423200 (Exp. 10/17), 418400 (Exp. 09/17), 411100 (Exp. 07/17), and 406500 (Exp. 06/17). Consumers and healthcare providers should discontinue use of these products and contact their pharmacist or healthcare provider for guidance.

The recalled product

Product
Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.
Manufacturer
VistaPharm, Inc.
Category
Drug — Antidiarrheal / Laxative
Hazard
Affected units
7,404

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • a). Lot No. 728300 (Exp. 11/17)
  • 423200 (Exp. 10/17)
  • 418400 (Exp. 09/17)
  • 411100 (Exp. 07/17)
  • 406500 (Exp. 06/17)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by VistaPharm, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Related recalls

Same manufacturer · VistaPharm, Inc.

See all →

Same hazard · bacterial contamination

See all →

Similar recalls