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Showing 3161–3180 of 3363 results

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Pulmicort Respules 0.25mg (AstraZeneca) – Specification Range (2013)

Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.

FDAJan 11, 2013Nationwide• AstraZeneca LP

Pulmicort Respules 0.5mg (AstraZeneca) – Specification Range (2013)

Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.

FDAJan 11, 2013Nationwide• AstraZeneca LP

Tausi Salted Black Beans (JMT Trading) – Swollen Cans (2013)

Reports were received of swollen cans of Tausi Salted Black Beans imported from the Philippines.

Class IIILow

FDAJan 10, 2013CA, HI, IN• JMT Trading Company, Inc.

Glycopyrrolate Tablets (West-ward) – Subpotent Drug (2013)

Subpotent Drug

FDAJan 7, 2013OH• West-ward Pharmaceutical Corp.

Bupropion XL Tablets (Actavis) – Dissolution Failure (2013)

Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.

FDAJan 4, 2013Nationwide• Actavis Pharmaceuticals

Coca-Cola (Coca-Cola Company) – off taste/odor (2013)

Complaints received of off taste/odor.

FDAJan 2, 2013FL• Coca-Cola Company (The)

Lac-Hydrin Lotion (Ranbaxy) – Crystallization Issue (2012)

Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.

FDADec 27, 2012Nationwide• Ranbaxy Inc.

Lac-Hydrin Cream (Ranbaxy) – Crystallization Issue (2012)

Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.

FDADec 27, 2012Nationwide• Ranbaxy Inc.

Thermo Rage Supplement (MET-Rx) – Bacterial Contamination (2012)

Acetobacter lovaniensis was detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage.

FDADec 21, 2012Nationwide• NBTY Inc.

Protein Shot (NBTY) – Bacterial Contamination (2012)

Lactobacillus plantarum and Lactobacillus brevis were detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage.

FDADec 21, 2012Nationwide• NBTY Inc.

Femtrace 0.9mg Tablets (Warner Chilcott) – Moisture Ingress (2012)

Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles

FDADec 21, 2012Nationwide• Warner Chilcott Company LLC

Femtrace 0.45mg Tablets (Warner Chilcott) – Moisture Ingress (2012)

Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles

FDADec 21, 2012Nationwide• Warner Chilcott Company LLC

Guava Mini Turnovers (Estrella) – Undeclared Red Dye (2012)

Undeclared Allergen

Undeclared Red #40

FDADec 21, 2012PR• Suadel Food Products, Inc.

Regular Wild Cherry Pepsi (Pepsi) – Mislabeled Bottles (2012)

The labels on two-liter batches of Regular and Diet Wild Cherry Pepsi were mistakenly swapped during production. This is potential safety issue for individuals who are sensitive to phenylalanine (i.e., phenylketonuric) or who are diabetic.

FDADec 20, 2012CT, ME, MA +2 more• Pepsi Cola North America

Flanax (Belmora LLC) – Defective Container (2012)

Defective Container: Product lacks tamper evident breakaway band on cap.

FDADec 18, 2012Nationwide• Belmora LLC

Vanilla Mini Roll (Father's Table) - Incorrect Labeling (2012)

Incorrectly labeled with a label that does not list strawberries and color additives (FC&C Red 40 and Blue 1).

FDADec 14, 2012AR, CA, NJ +8 more• The Father's Table, LLC

Vanilla Roll (Father's Table) - Incorrect Labeling (2012)

Incorrectly labeled with a label that does not list strawberries and color additives (FC&C Red 40 and Blue 1).

FDADec 14, 2012AR, CA, NJ +8 more• The Father's Table, LLC

Caziant Tablets (Watson Laboratories) – Impurity Concern (2012)

Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.

FDADec 13, 2012Nationwide• Watson Laboratories Inc

Perindopril Erbumine Tablets (Boehringer Ingelheim) – Impurity Risk (2012)

Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.

FDADec 12, 2012Nationwide• Boehringer Ingelheim Roxane Inc

Redskin Peanuts (Meijer) – Incorrect Sodium Label (2012)

Sodium was not correctly stated on the label.

FDADec 11, 2012IL, IN, KY +2 more• Meijer Distribution, Inc

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