The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0458-2017·Announced 2017-02-08

VistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Contamination

VistaPharm is recalling Hydrocodone Bitartrate and Acetaminophen Oral Solution 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 and involves potential contamination with Burkholderia cepacia, a pathogen associated with serious infections, meeting the criteria for a Severe rating.

Plain-English summary

VistaPharm, Inc. is recalling Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL, in various package sizes including 4 fl. oz. bottles, 16 fl. oz. bottles, and 50 unit dose cups. The recall affects 32,027 bottles and 16,310 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. The affected lots include Lot No. 419000, 419800, 429100, 418200, 430100, 423800, 413100, and 410700, with expiration dates ranging from January 2017 to June 2017.

Consumers and healthcare providers should stop using the affected products and contact their pharmacist or healthcare provider for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

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) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx…
Manufacturer
VistaPharm, Inc.
Category
Drug — Oral Solution
Hazard

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 (6)

  • 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)

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