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Showing 2621–2640 of 3363 results

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Simvastatin Tablets 40mg (Micro Labs) – Impurity Specification (2014)

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

FDADec 4, 2014Nationwide• Micro Labs Usa, Inc S

Eye Drops A.C. (K C Pharmaceuticals) – Non-Compliant Storage (2014)

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

FDADec 4, 2014Nationwide• K C Pharmaceuticals Inc

Simvastatin Tablets 20mg (Micro Labs) – Impurity Specification (2014)

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

FDADec 4, 2014Nationwide• Micro Labs Usa, Inc S

Eye Drops (K C Pharmaceuticals) – Non-Compliant Storage (2014)

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

FDADec 4, 2014Nationwide• K C Pharmaceuticals Inc

Simvastatin Tablets 80mg (Micro Labs) – Impurity Specification (2014)

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

FDADec 4, 2014Nationwide• Micro Labs Usa, Inc S

Eye Drops Advanced Relief (K C Pharmaceuticals) – Non-Compliant Storage (2014)

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

FDADec 4, 2014Nationwide• K C Pharmaceuticals Inc

Rogalik Papaya (Golden Chocolate) – Undeclared Food Coloring (2014)

Undeclared Allergen

Golden Chocolate International, Inc. has recalled (3) products due to the use of undeclared FD&C Yellow #5, FD&C Yellow #6, and FD&C Red #40 food colorings.

FDANov 27, 2014NY, PA• Golden Chocolate International, Inc.

Raisin Pound Cake (Golden Chocolate) – Undeclared Food Coloring (2014)

Undeclared Allergen

Golden Chocolate International, Inc. has recalled (3) products due to the use of undeclared FD&C Yellow #5, FD&C Yellow #6, and FD&C Red #40 food colorings.

FDANov 27, 2014NY, PA• Golden Chocolate International, Inc.

Orex (Golden Chocolate) – Undeclared Food Coloring (2014)

Undeclared Allergen

Golden Chocolate International, Inc. has recalled (3) products due to the use of undeclared FD&C Yellow #5, FD&C Yellow #6, and FD&C Red #40 food colorings.

FDANov 27, 2014NY, PA• Golden Chocolate International, Inc.

Lacrimedics Inc: VisiPlugST for the Lacrimal Efficiency Test. It is also ...

Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon contact. The firm's data also suggests that a 4 year shelf life may not be sustained.

FDANov 26, 2014Nationwide• Lacrimedics Inc

Dacarbazine Injection (Hospira) – Discoloration Issue (2014)

Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.

FDANov 25, 2014Nationwide• Hospira Inc.

Bee Flower Honey (Vintage Food) – Sulfamethazine Levels (2014)

Product contains higher than recommended levels of sulfamethazine.

FDANov 25, 2014CT, DE, FL +14 more• Vintage Food Corp.

Dasani Purified Water (Coca Cola Bottling) – potential mold (2014)

An equipment malfunction during production that may have led to the appearance of mold in some product.

FDANov 24, 2014AL, FL, GA +1 more• Coca Cola Bottling Company United, LLC

Fabulous Fudge Gift Box (Tastefully Simple) – mold growth (2014)

Tastefully Simple is recalling various lots of Cookie & Cream Fudge(Fabulous Fudge Gift) because the product appears to have mold growing on the small chocolate cookie pieces on the top of the Cookies & Cream Fudge.

FDANov 18, 2014Nationwide• Tastefully Simple, Inc

Clark Laboratories, Inc. (dba,Trinity Biotech USA): Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit...

Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.

FDANov 17, 2014CA, FL, NY +1 more• Clark Laboratories, Inc. (dba,Trinity Biotech USA)

5-HTP Extra Strength (Nutri-Dyn) – mislabeling (2014)

Nutri-Dyn has initiated a recall due to mislabeling. During production of CoQ-10, Lot #140186, one or more bottles were mistakenly labeled as 5-HTP Extra Strength.

FDANov 17, 2014AZ, CO, IN +10 more• Nutri-Dyn Midwest, Inc.

Aesculap, Inc.: Aesculap Miethke Shunt System, miniNAV Valve: The Miethke...

Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.

FDANov 11, 2014IN, OK, WI• Aesculap, Inc.

Mucinex DM (Reckitt Benckiser) – Defective Container Seal (2014)

Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch

FDANov 10, 2014Nationwide• Reckitt Benckiser LLC

Tecan US, Inc.: Infinite 200 The Tecan Infinite 200 is a multifunctional...

Incorrect lumi firmware version installed (E.027 instead of V2.00)

FDANov 10, 2014MD• Tecan US, Inc.

Tecan US, Inc.: Infinite 200PRO The Tecan Infinite 200 is a multifunctio...

Incorrect lumi firmware version installed (E.027 instead of V2.00)

FDANov 10, 2014MD• Tecan US, Inc.

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