Why it was recalled
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Product description
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01
Lot numbers, UPCs & expiration codes
Lot# 100025842, 100028023, Exp Date 08/2023
Where it was sold
Nationwide in the USA
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-0461-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 18, 2022
- FDA report date
- Feb 9, 2022
- Quantity
- 6205 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0461-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89422
- Address
- 400 Interpace Pkwy
- Code information
- Lot# 100025842, 100028023, Exp Date 08/2023
- Postal code
- 07054-1120
- Report date
- Feb 9, 2022
- Product type
- Drugs
- Recall number
- D-0461-2022
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 6205 100-count bottles
- Termination date
- Dec 21, 2022
- Reason for recall
- Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 18, 2022
- Center classification date
- Jan 28, 2022