VistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Impurities
VistaPharm is recalling specific lots of Hydrocodone Bitartrate & Acetaminophen Oral Solution because impurities exceeded specifications during stability testing.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as the agency's own classification mandates a minimum score of 4.
Plain-English summary
VistaPharm, Inc. is recalling Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL. The recall includes 15 mL Unit Dose Cups (NDC 66689-023-50) and 473 mL Bottles (NDC 66689-023-16). The affected lots are 251400 and 251500, both with an expiration date of 07/13.
The recall was initiated because impurities or degradation products exceeded specifications during 3-month stability testing. The agency has classified this as a Class II recall. The affected products were distributed nationwide.
Consumers should check their medication for the specific NDC numbers and lot numbers listed above. If the product matches the recalled items, they should stop using it and contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC…
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Oral Solution
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 (3)
- Lot #'s a) 251400
- Exp 07/13
- b) 251500 Exp 07/13.
Distribution
Distributed nationwide across the United States.
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