Reported Jun 19, 2019 · Terminated
PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd.,…
Heritage Pharmaceuticals, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heritage Pharmaceuticals, Inc. · 1 Tower Center Blvd Ste 1700 · East Brunswick, NJ · 08816-1145
Is this the product you have?
- PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only
- Mfg byEmcure Pharmaceuticals Ltd., Hinjawadi, Pune, India
- Mfg forHeritage Pharmaceuticals Inc. NDC 23155-294-31
- Lot codes and dates
- Lot
VPCA172EXP April 2020
- Lot
- Amount recalled
- 55,480 2 mL vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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