29 FDA recalls mention Diclofenac. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Diclofenac.
Reason Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Reason Failed PH Specifications
Reason Defective Delivery System
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability…
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason Defective Container: Leaking containers.
Reason Defective container: Out of specification for container integrity leading to bottles leaking.
Reason Defective Container
Reason Defective Container
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Reason Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Lack of Processing Controls
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Reason Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Reason Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Reason Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Reason Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Reason Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the…
Reason Failed Tablet/Capsule Specifications: Broken tablets
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