Class II · Moderate risk Ongoing
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540…
Reason Failed Impurities/Degradation Specifications
Is Olanzapine recalled?
20 FDA recalls mention Olanzapine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Olanzapine.
Class II · Moderate risk Terminated
Olanzapine Orally Disintegrating Tablets, USP 10 mg, 30-count box unit dose tablets (3 blister cards each containing 10 tablets)…
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Olanzapine single dose vial Lyophilized, 10 mg, Rx only, MFG: Auromedics Pharma LLC, NDC# 55150-0308-01
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536…
Reason cGmp Deviations
Class II · Moderate risk Terminated
Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis…
Reason cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Class III · Low risk Terminated
Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant…
Reason Subpotent
Class III · Low risk Terminated
Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured…
Reason Failed Impurities/ Degradation Specifications
Class III · Low risk Terminated
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured…
Reason Failed Impurities/ Degradation Specifications
Class III · Low risk Terminated
Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c)…
Reason Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk Terminated
Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c)…
Reason Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk Terminated
Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c)…
Reason Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk Terminated
Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512…
Reason Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk Terminated
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally…
Reason Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18…
Class III · Low risk Terminated
Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada…
Reason Subpotent drug
Class III · Low risk Terminated
Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC…
Reason Subpotent drug
Class III · Low risk Terminated
Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC…
Reason Subpotent drug
Class III · Low risk Terminated
Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada…
Reason Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Class II · Moderate risk Terminated
Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by…
Reason Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material…
Class II · Moderate risk Terminated
OLANZAPINE, Tablet 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505311203
Reason Labeling:Label Mixup; OLANZAPINE, Tablet 7.5 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC 00093081301, Pedigree…
Class II · Moderate risk Terminated
OLANZapine Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111016530
Reason Labeling:Label Mixup; OLANZapine, Tablet, 7.5 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 175 mcg, NDC 00527135001…
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