Why it was recalled
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Product description
Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ --- NDC 57237-041-99
Lot numbers, UPCs & expiration codes
Batch Numbers: PE5015069-A, exp 11/2018
Where it was sold
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-0652-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 24, 2017
- FDA report date
- Apr 19, 2017
- Quantity
- 420 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Citron Pharma Llc
Original FDA data
Every field from FDA enforcement report D-0652-2017, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76738
- Address
- 2 Tower Center Blvd Ste 1101
- Code information
- Batch Numbers: PE5015069-A, exp 11/2018
- Postal code
- 08816-1100
- Report date
- Apr 19, 2017
- Product type
- Drugs
- Recall number
- D-0652-2017
- Classification
- Class III
- Recalling firm
- Citron Pharma Llc
- Product quantity
- 420 bottles
- Termination date
- Sep 9, 2019
- Reason for recall
- Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ --- NDC 57237-041-99
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 24, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 7, 2017