🍔 Food 💊 Drugs 🏥 Medical Devices
Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons. Class III

Reason: Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

PACK Pharmaceuticals, LLC 20130909 Terminated
Distributed: Nationwide and Puerto Rico.
View Details
Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons. Class III

Reason: Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

PACK Pharmaceuticals, LLC 20130909 Terminated
Distributed: Nationwide and Puerto Rico.
View Details
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons. Class III

Reason: Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

PACK Pharmaceuticals, LLC 20130909 Terminated
Distributed: Nationwide and Puerto Rico.
View Details
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons. Class III

Reason: Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

PACK Pharmaceuticals, LLC 20130909 Terminated
Distributed: Nationwide and Puerto Rico.
View Details
Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons. Class III

Reason: Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

PACK Pharmaceuticals, LLC 20130909 Terminated
Distributed: Nationwide and Puerto Rico.
View Details
Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons. Class III

Reason: Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

PACK Pharmaceuticals, LLC 20130909 Terminated
Distributed: Nationwide and Puerto Rico.
View Details
HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433. Class II

Reason: Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)

Health & Beyond 20130515 Terminated
Distributed: Product was distributed to consumers through firm's website in Florida, Hawaii, California, Illinois, New York, Washington, and Pennsylvania.
View Details
The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry. Class II

Reason: Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.

Apothecure, Inc 20130415 Terminated
Distributed: Nationwide
View Details
Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05. Class III

Reason: Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.

Forest Pharmaceuticals Inc 20131113 Terminated
Distributed: Nationwide and Puerto Rico.
View Details
Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29. Class III

Reason: Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.

Forest Pharmaceuticals Inc 20131113 Terminated
Distributed: Nationwide and Puerto Rico.
View Details
Page 1,555 of 1,805 | Showing 10 recalls
Data provided by openFDA