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Showing 3241–3260 of 3363 results

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Hydroxyzine Hydrochloride Oral Solution (Vintage Pharmaceuticals) – impurity risk (2012)

Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.

FDAJul 6, 2012Nationwide• Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Carboplatin Injection (Hospira) – pH specification failure (2012)

Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.

FDAJul 2, 2012Nationwide

• Hospira Inc.

Nexium Capsules (Astra Zeneca) – foreign tablet mix (2012)

Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.

FDAJul 2, 2012Nationwide• ASTRA ZENECA Lp

Frozen Pangasius Fish (Nha Trang Seafoods) – nitrofuran detected (2012)

The product was recalled because nitrofuran residue was detected.

FDAJul 2, 2012CA, IN• Nha Trang Seafoods, Inc

Coconut Water (Aloha Maid) – Off-Smell Product (2012)

Product has off-smell and off-taste and should not be consumed.

FDAJun 29, 2012HI, IN• Itoen (USA) Inc

Famotidine Tablets (Mylan) – Impurity Concern (2012)

Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.

FDAJun 28, 2012Nationwide• Mylan Pharmaceuticals Inc.

Super Colon Cleanse (Health Plus) – Labeling Mistake (2012)

Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.

FDAJun 28, 2012Nationwide• Health Plus Incorporated

Nesquik Chocolate (Nestle) – Metal Contamination (2012)

Firm initiated recall due to potential contamination with metal fragments.

FDAJun 27, 2012IN, TX• Nestle USA

Lactated Ringer's Injection (Hospira) – CGMP Deviations (2012)

CGMP Deviations: Shipment of product not approved for release.

FDAJun 21, 2012NC• Hospira, Inc.

Tobramycin Ophthalmic Ointment (Stat Rx) – Labeling Mixup (2012)

Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."

FDAJun 18, 2012FL, PA, VA• Stat Rx USA

Eroxil Tablets (H & L Jerch) – Botanical Ingredient Concerns (2012)

The products contain synthetic equivalents of spermine and/or spermidine, which are constituents or extracts of an herb or other botanical, and the that a synthetic copy of a constituent or extract of an herb or other botanical is not a dietary ingredient, and such ingredients must be approved for use in supplements. The use has not been approved.

FDAJun 11, 2012Nationwide• H & L Jerch Sales, Inc.

Erosyn Tablets (H & L Jerch) – Botanical Ingredient Concerns (2012)

The products contain synthetic equivalents of spermine and/or spermidine, which are constituents or extracts of an herb or other botanical, and the that a synthetic copy of a constituent or extract of an herb or other botanical is not a dietary ingredient, and such ingredients must be approved for use in supplements. The use has not been approved.

FDAJun 11, 2012Nationwide• H & L Jerch Sales, Inc.

Middle-Age Energy Booster (H & L Jerch) – Botanical Ingredient Concerns (2012)

The products contain synthetic equivalents of spermine and/or spermidine, which are constituents or extracts of an herb or other botanical, and the that a synthetic copy of a constituent or extract of an herb or other botanical is not a dietary ingredient, and such ingredients must be approved for use in supplements. The use has not been approved.

FDAJun 11, 2012Nationwide• H & L Jerch Sales, Inc.

Fertalin Tablets (H & L Jerch) – Botanical Ingredient Concerns (2012)

The products contain synthetic equivalents of spermine and/or spermidine, which are constituents or extracts of an herb or other botanical, and the that a synthetic copy of a constituent or extract of an herb or other botanical is not a dietary ingredient, and such ingredients must be approved for use in supplements. The use has not been approved.

FDAJun 11, 2012Nationwide• H & L Jerch Sales, Inc.

Erythromycin Topical Solution (Fougera) – Chemical Contamination (2012)

Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.

FDAJun 7, 2012Nationwide• Fougera Pharmaceuticals, Inc.

Oyster Stew (Campbell's) – Insanitary Conditions (2012)

The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

FDAJun 5, 2012Nationwide• Campbell Soup Supply Co., LLC

Pitocin Injection (JHP Pharmaceuticals) – Labeling Error (2012)

Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".

FDAJun 5, 2012Nationwide• JHP Pharmaceuticals, LLC

Caziant Tablets (Watson Labs) – Impurity Issues (2012)

Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.

FDAJun 5, 2012Nationwide• Watson Laboratories Inc

Queso Pringles (Kellogg) – Flavoring Ingredient Issue (2012)

Queso flavored Pringles, 40 gram and 139 gram sizes, sent to distribution centers in Mexico and Grenada are being recalled because the flavoring ingredient ( under a separate recall) may be contaminated with metal fragments. Pringles processing includes metal fragment seasoning screening and finished product metal detection to 1. 4 mm size. Pringle's product containing the recalled seasoning

FDAJun 4, 2012Nationwide• Kellogg Company

California Girl Whole Boiled Oysters (Atlapac) – Unsanitary Conditions (2012)

The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

FDAJun 1, 2012Nationwide• Atlapac Trading Company Inc

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