Drugs Recalls

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

Presence of Foreign Tablets/Capsules

Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

Failed Impurities/Degradation Specifications.

Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack

Failed Dissolution Specifications

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).

Lack of Assurance of Sterility

Lack of Assurance of Sterility

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.

Lack of Assurance of Sterility

Lack of Assurance of Sterility