Ronkonkoma, NY, United States
Spirit Pharmaceuticals, LLC recalls
2 recalls recorded since 2018, most recently on 16 June 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 16 June 2021
- Terminated
- 7 September 2022
- Reason
- cGMP deviations: Discolored acetaminophen
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0729-2021
- Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10
Terminated Class II Drugs
- Recall started
- 10 January 2018
- Terminated
- 20 January 2021
- Reason
- CGMP deviations: Ibuprofen is being recalled in response to previous recall
- Distribution
- NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0583-2018
- Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.