Class II · Moderate risk Ongoing
Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur…
Reason CGMP Deviations
Is Prochlorperazine recalled?
3 FDA recalls mention Prochlorperazine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Prochlorperazine.
Class III · Low risk Terminated
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland…
Reason Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Class I · High risk Terminated
PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi…
Reason Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection…
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