FDA Drug recall D-1306-2020
Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Divisio…
- FDA Drug
- Class II
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Divisio… by Pfizer, citing presence of Particulate Matter: particulate matter identified after reconstitution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1306-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-29 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
Product
Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83
Reason
Presence of Particulate Matter: particulate matter identified after reconstitution.
Identifiers
| ndc | 0049-0013-81 |
|---|---|
| ndc | 0049-0013-83 |
| ndc | 0049-0014-81 |
| ndc | 0049-0014-83 |
| ndc | 0049-0710-01 |
| ndc | 0049-0710-10 |
| ndc | 0049-3003-01 |
| ndc | 0049-3003-10 |
| code_info | Lot # 3301612, EXP 02/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Pfizer
- Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL…
FDA Drug · Class II · 2026-09-23 · Pfizer - Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-66…
FDA Drug · Class II · 2025-08-27 · Pfizer - Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4…
FDA Drug · Class II · 2025-08-27 · Pfizer - Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Au…
FDA Drug · Class II · 2025-08-20 · Pfizer - Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New…
FDA Drug · Class II · 2025-08-06 · Pfizer
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1306-2020%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.