Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
8.4% Sodium Bicarbonate Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter; glass particulates
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02
Affected NDC
0409-6625-02
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sodium Bicarbonate NDC 00409-6625 |
84 mg/mL | Injection, Solution Intravenous |
Hospira, Inc. | Rx |
- Recalling firm
- Pfizer Inc.
- NDC code
- 0409-6625-02
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1073-2019 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Pfizer Inc.
All 2019 recalls
Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
Other particulate / foreign matter recalls from 2019
All particulate / foreign matter recalls
Class I · High risk
Ketorolac Trom
Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
Class I · High risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Class II · Moderate risk
Amantadine Hydrochloride Tablets
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
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