Why it was recalled
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Product 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
Lot numbers, UPCs & expiration codes
Lot #: 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0532-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 1, 2019
- FDA report date
- Nov 20, 2019
- Quantity
- 1534 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KVK-Tech, Inc.
Original FDA data
Every field from FDA enforcement report D-0532-2020, exactly as published.
Show all FDA fields
- City
- Newtown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 84184
- Address
- 110 Terry Dr
- Code information
- Lot #: 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN
- Postal code
- 18940-3427
- Report date
- Nov 20, 2019
- Product type
- Drugs
- Recall number
- D-0532-2020
- Classification
- Class II
- Recalling firm
- KVK-Tech, Inc.
- Product quantity
- 1534 bottles
- Termination date
- Apr 16, 2020
- Reason for recall
- Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 1, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 29, 2019