Class II · Moderate risk
Prochlorperazine Maleate Tablets
CGMP Deviations
Prochlorperazine Edisylate Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
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) .
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31
Affected NDC
23155-0294-31
Compare with the code on your package — it is the most precise check available.
Drug: Prochlorperazine
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 |
|---|---|---|---|---|
| Prochlorperazine Edisylate NDC 23155-0294 |
5 mg/mL | Injection Intramuscular|intravenous |
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | Rx |
- Recalling firm
- Heritage Pharmaceuticals, Inc.
- NDC code
- 23155-294-31
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1397-2019 · 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 Prochlorperazine recalls
See all
Class III · Low risk
Prochlorperazine Maleate Tablets
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Other recalls by Heritage Pharmaceuticals, Inc.
All 2019 recalls
Class II · Moderate risk
Clindamycin Palmitate Hydrochloride for Oral Solution
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
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