Why it was recalled
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Product description
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
Lot numbers, UPCs & expiration codes
Lot # WP5K0Y, exp. date 02/28/2023
Where it was sold
Product was distributed 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-0794-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 19, 2021
- FDA report date
- Sep 22, 2021
- Quantity
- 55,344/100 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rhodes Pharmaceuticals, L.P.
Original FDA data
Every field from FDA enforcement report D-0794-2021, exactly as published.
Show all FDA fields
- City
- Coventry
- State
- RI
- Status
- Terminated
- Country
- United States
- Event ID
- 88506
- Address
- 498 Washington St
- Code information
- Lot # WP5K0Y, exp. date 02/28/2023
- Postal code
- 02816-5467
- Report date
- Sep 22, 2021
- Product type
- Drugs
- Recall number
- D-0794-2021
- Classification
- Class II
- Recalling firm
- Rhodes Pharmaceuticals, L.P.
- Product quantity
- 55,344/100 count bottles
- Termination date
- Mar 7, 2023
- Reason for recall
- Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed nationwide.
- Recall initiation date
- Aug 19, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 13, 2021