Recalls / Class III
Class IIID-0652-2017
Product
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
- Brand name
- Penicillin V Potassium
- Generic name
- Penicillin V Potassium
- Active ingredient
- Penicillin V Potassium
- Route
- Oral
- NDCs
- 57237-040, 57237-041
- FDA application
- ANDA065435
- Affected lot / code info
- Batch Numbers: PE5015069-A, exp 11/2018
Why it was recalled
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Recalling firm
- Firm
- Citron Pharma Llc
- Manufacturer
- Rising Health, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1101, N/A, East Brunswick, New Jersey 08816-1100
Distribution
- Quantity
- 420 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-02-24
- FDA classified
- 2017-04-07
- Posted by FDA
- 2017-04-19
- Terminated
- 2019-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0652-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.