Why it was recalled
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Product description
ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH 45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045; NDC 68645-493-54.
Lot numbers, UPCs & expiration codes
Lot # 161901, Exp 04/18
Where it was sold
Product was shipped to distribution centers in TN, IN, and AZ then further shipped the product to retail pharmacies 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-0606-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 7, 2017
- FDA report date
- Mar 29, 2017
- Quantity
- 48,012 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Legacy Pharmaceutical Packaging LLC
Original FDA data
Every field from FDA enforcement report D-0606-2017, exactly as published.
Show all FDA fields
- City
- Earth City
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 76666
- Address
- 13333 Lakefront Dr
- Code information
- Lot # 161901, Exp 04/18
- Postal code
- 63045-1514
- Report date
- Mar 29, 2017
- Product type
- Drugs
- Recall number
- D-0606-2017
- Classification
- Class II
- Recalling firm
- Legacy Pharmaceutical Packaging LLC
- Product quantity
- 48,012 bottles
- Termination date
- Aug 23, 2019
- Reason for recall
- Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH 45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045; NDC 68645-493-54.
- Distribution pattern
- Product was shipped to distribution centers in TN, IN, and AZ then further shipped the product to retail pharmacies nationwide in the USA.
- Recall initiation date
- Mar 7, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 21, 2017