Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Heartburn & Stomach Medication Recalls
Recalls of acid reducers and stomach drugs - the class behind the ranitidine (Zantac) nitrosamine recalls.
211 recalls in this category, newest first.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Famotidine Tablets
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Class II · Moderate risk
Ranitidine various strengths in syringes
Lack of sterility assurance.
Class II · Moderate risk
Ranitidine HCl active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Pantoprazole Sodium Monohydrate active pharmaceutical ingredient…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Ondansetron HCl Dihydrate active pharmaceutical ingredient…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Omeprazole Sodium active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Omeprazole active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Famotidine active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Esomeprazole Magnesium Trihydrate active pharmaceutical…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Famotidine for Oral Suspension
Failed Impurity/Degradation Specification; 12-month stability time point
Class II · Moderate risk
Famotidine Injection 20 mg
Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
Class II · Moderate risk
Pantoprazole Sodium
Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets
Class II · Moderate risk
Ranitidine Tablets USP
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.
Class II · Moderate risk
Ondansetron Injection
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Class II · Moderate risk
Ranitidine Hydrochloride Tablets
Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
Class II · Moderate risk
Pantoprazole Sodium Dr
Labeling: Label Mixup: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD60272_16, EXP: 5/22/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 65162066810, Pedigree: AD73646_13, EXP: 5/30/2014.
Class II · Moderate risk
PANTOPRAZOLE SODIUM DR Tablet
Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 40 mg may be potentially mislabeled as SENNOSIDES, Tablet, 8.6 mg, NDC 60258095001, Pedigree: AD37063_17, EXP: 5/13/2014.
Class II · Moderate risk
PANTOPRAZOLE SODIUM DR Tablet
Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014.
Class II · Moderate risk
PANTOPRAZOLE SODIUM DR Tablet
Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as DRONEDARONE HCL, Tablet, 400 mg, NDC 00024414260, Pedigree: AD52778_52, EXP: 5/20/2014.
Class II · Moderate risk
FAMOTIDINE Tablet
Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003507, EXP: 6/21/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 0037822500
Class II · Moderate risk
Pantoprazole Sodium Dr
Labeling: Label Mixup; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabel as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC 00093081301, Pedigree: W003694, EXP: 6/26/2014.
Class II · Moderate risk
Omeprazole/Sodium Bicarbonate
Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD70655_8, EXP: 5/29/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD73627_32, EXP: 5/30/2014.
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