Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg Recalled by KVK-Tech, Inc. Due to Presence of Foreign Substance: Black particles were found...

Date: November 1, 2019
Company: KVK-Tech, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact KVK-Tech, Inc. directly.

Affected Products

Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16

Quantity: 1534 bottles

Why Was This Recalled?

Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About KVK-Tech, Inc.

KVK-Tech, Inc. has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report