Recalls / Class II
Class IID-0794-2021
Product
Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-002-01
- Brand name
- Oxycodone Hydrochloride
- Generic name
- Oxycodone Hydrochloride
- Active ingredient
- Oxycodone Hydrochloride
- Route
- Oral
- NDCs
- 42858-001, 42858-002, 42858-003, 42858-004, 42858-005
- FDA application
- ANDA091490
- Affected lot / code info
- Lot # WP5K0Y, exp. date 02/28/2023
Why it was recalled
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Recalling firm
- Firm
- Rhodes Pharmaceuticals, L.P.
- Manufacturer
- Rhodes Pharmaceuticals L.P.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 498 Washington St, N/A, Coventry, Rhode Island 02816-5467
Distribution
- Quantity
- 55,344/100 count bottles
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2021-08-19
- FDA classified
- 2021-09-13
- Posted by FDA
- 2021-09-22
- Terminated
- 2023-03-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0794-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.