FDA Drug recall D-0581-2022
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177…
- FDA Drug
- Class II
- terminated
- Published 2022-03-02
On 2022-03-02 the FDA classified a Class II recall of Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177… by Perrigo, citing CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0581-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-26 |
| Published | 2022-03-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Perrigo |
| Distribution | US |
Product
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1321-97
Reason
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Identifiers
| ndc | 0536-1321-97 |
|---|---|
| code_info | Batch: 1BK0960, Exp 12/31/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0581-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.