Why it was recalled
Product Mix-up
Product description
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.
Lot numbers, UPCs & expiration codes
Lot #: 21070817, Exp 6/2023
Where it was sold
USA Nationwide
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-0276-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 19, 2021
- FDA report date
- Dec 15, 2021
- Quantity
- 9744 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascent Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0276-2022, exactly as published.
Show all FDA fields
- City
- Central Islip
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89060
- Address
- 400 S Technology Dr
- Code information
- Lot #: 21070817, Exp 6/2023
- Postal code
- 11722-4402
- Report date
- Dec 15, 2021
- Product type
- Drugs
- Recall number
- D-0276-2022
- Classification
- Class II
- Recalling firm
- Ascent Pharmaceuticals, Inc.
- Product quantity
- 9744 bottles
- Termination date
- Dec 6, 2023
- Reason for recall
- Product Mix-up
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Nov 19, 2021
- Initial firm notification
- Letter
- Center classification date
- Dec 7, 2021