FDA Drug recall D-1513-2016
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-0…
- FDA Drug
- Class II
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class II recall of Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-0… by Sandoz, citing lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1513-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-24 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | US |
Product
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Reason
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Identifiers
| code_info | Lot #: 080514, 080614, 081114, 081214, 081314, 081414, 082714, 082814, 082914, Exp 08/16; 090214, 090314, 090814, 09091…Lot #: 080514, 080614, 081114, 081214, 081314, 081414, 082714, 082814, 082914, Exp 08/16; 090214, 090314, 090814, 090914, 091014, 091114, 091214, 091514, Exp 09/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Sandoz
- Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC,…
FDA Drug · Class III · 2026-06-24 · Sandoz - Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fa…
FDA Drug · Class II · 2025-09-24 · Sandoz - Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgiu…
FDA Drug · Class II · 2025-09-17 · Sandoz - Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sand…
FDA Drug · Class I · 2025-07-09 · Sandoz - Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austr…
FDA Drug · Class I · 2025-07-09 · Sandoz
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1513-2016%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.