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Showing 27681–27700 of 29086 results

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Ethambutol Tablets (West-ward) - tablet discoloration (2012)

Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.

Class IIModerate

FDANov 30, 2012GA• West-ward Pharmaceutical Corp.

Lisinopril Hydrochlorothiazide (West-ward) - steel particulates (2012)

Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.

Class IIModerate

FDANov 30, 2012Nationwide• West-ward Pharmaceutical Corp.

NorthStar Arthritis Cream (Mariposa) - microbial contamination (2012)

Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications.

Class IIModerate

FDANov 29, 2012IN• Mariposa Labs, LLC

Primarque Lobster Base (Williams West & Witt's) – undeclared milk (2012)

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Class IIModerate

FDANov 28, 2012IL, IN, KY +3 more• Williams West & Witt's Products Company

Lobster Base (Williams West & Witt's) – Undeclared Milk (2012)

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Class IIModerate

FDANov 28, 2012IL, IN, KY +3 more• Williams West & Witt's Products Company

Primarque Clam Base (Williams West & Witt's) – undeclared milk (2012)

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Class IIModerate

FDANov 28, 2012IL, IN, KY +3 more• Williams West & Witt's Products Company

Cook's Delight Shrimp Base (Williams West & Witt's) – undeclared milk (2012)

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Class IIModerate

FDANov 28, 2012IL, IN, KY +3 more• Williams West & Witt's Products Company

Primarque Crab Base (Williams West & Witt's) – undeclared milk (2012)

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Class IIModerate

FDANov 28, 2012IL, IN, KY +3 more• Williams West & Witt's Products Company

Primarque Clam Base (Williams West & Witt's) – undeclared milk (2012)

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Class IIModerate

FDANov 28, 2012IL, IN, KY +3 more• Williams West & Witt's Products Company

Cook's Delight Lobster Base (Williams West & Witt's) – undeclared milk (2012)

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Class IIModerate

FDANov 28, 2012IL, IN, KY +3 more• Williams West & Witt's Products Company

Seafood Base (Williams West & Witt's) – Undeclared Milk (2012)

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Class IIModerate

FDANov 28, 2012IL, IN, KY +3 more• Williams West & Witt's Products Company

Primarque Clam Base (Williams West & Witt's) – undeclared milk (2012)

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Class IIModerate

FDANov 28, 2012IL, IN, KY +3 more• Williams West & Witt's Products Company

Piazza Produce Clam Base (Williams West & Witt's) – undeclared milk (2012)

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Class IIModerate

FDANov 28, 2012IL, IN, KY +3 more• Williams West & Witt's Products Company

Fish Base (Williams West & Witt's) – Undeclared Milk (2012)

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Class IIModerate

FDANov 28, 2012IL, IN, KY +3 more• Williams West & Witt's Products Company

Cook's Delight Mushroom Base (Williams West & Witt's) – undeclared milk (2012)

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Class IIModerate

FDANov 28, 2012IL, IN, KY +3 more• Williams West & Witt's Products Company

Cook's Delight Shrimp Base (Williams West & Witt's) – undeclared milk (2012)

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Class IIModerate

FDANov 28, 2012IL, IN, KY +3 more• Williams West & Witt's Products Company

Nalbuphine HCl Injection (Hospira) – sterility concern (2012)

Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.

Class IIModerate

FDANov 21, 2012Nationwide• Hospira, Inc.

Fluorouracil Topical Cream (Taro) – stability issues (2012)

Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.

Class IIModerate

FDANov 21, 2012Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Propranolol Extended-release Capsules (Upsher) – dissolution failure (2012)

Failed Dissolution Test Requirements

Class IIModerate

FDANov 20, 2012FL, NJ• Upsher Smith Laboratories, Inc.

Organic Orzo (365) – manufacturing hold (2012)

This product (one specific lot code) was being held at the manufacturers' request in distribution centers upon receiving. The vendor had an initial positive result for egg protein in one of their regularly scheduled tests, but it occurred after the product had shipped. The manufacturer tested again when they received a second positive result. At this time the manufacturer authorized Whole Foods Ma

Class IIModerate

FDANov 20, 2012AL, GA, MD +7 more• Whole Foods Market

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