rOPINIRole Tablets USP 4 mg* 100-count bottle recall: CGMP Deviations
rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas…
Why was rOPINIRole Tablets USP 4 mg* 100-count bottle recalled?
CGMP Deviations: recalling drug products following an FDA inspection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batches: P2106136, Exp. Date 8/31/2023, P2106813, P2106814, Exp. Date 9/30/2023, P2202764, Exp. Date 4/30/2024
- Product
- rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas…
- Recalling firm
- Accord Healthcare, Inc.
- Quantity
- 8,184 bottles
- Distribution
- United States including Puerto Rico and Canada
- Recall date
- March 8, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)