Drug recall
Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC…
FDA recall event 90682 · Class III · Akron Pharma, Inc.
Key facts
| Event ID | 90682 |
|---|---|
| Recall numbers | D-1352-2022, D-1353-2022 |
| Recalling firm | Akron Pharma, Inc. |
| Product type | Drugs |
| Products | Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ, Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet. |
| Initiation date | Aug 4, 2022 |
| Report date | Aug 24, 2022 |
| Termination date | Dec 4, 2023 |
| City | Fairfield |
| State | NJ |
| Country | United States |
| FEI number | 3013943804 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: