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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- KVK-Tech, Inc.
- Reason for Recall:
- Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
Lot #: 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0532-2020
Related Recalls
Class I - Dangerous
cGMP deviations
Class I - Dangerous
cGMP deviations
Class I - Dangerous
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.