Why it was recalled
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Product description
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722, NDC 31722-943-01
Lot numbers, UPCs & expiration codes
Lot #: 20070518, Exp. Date June 2022
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-0097-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 26, 2020
- FDA report date
- Nov 25, 2020
- Quantity
- 9768 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascent Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0097-2021, exactly as published.
Show all FDA fields
- City
- Central Islip
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 86665
- Address
- 400 S Technology Dr
- Code information
- Lot #: 20070518, Exp. Date June 2022
- Postal code
- 11722-4402
- Report date
- Nov 25, 2020
- Product type
- Drugs
- Recall number
- D-0097-2021
- Classification
- Class II
- Recalling firm
- Ascent Pharmaceuticals, Inc.
- Product quantity
- 9768 Bottles
- Termination date
- Feb 17, 2023
- Reason for recall
- Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722, NDC 31722-943-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 26, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 17, 2020