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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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.
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