Zenatane (isotretinoin) capsules, 20 mg recall — FDA D-0507-2017
Failed dissolution specifications - low dissolution results at S3 stage.
Overview of recall records associated with Dr. Reddy's Laboratories, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 50, Class III: 33, Class I: 3.
Failed dissolution specifications - low dissolution results at S3 stage.
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for…
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Subpotent Drug: Subpotent atorvastatin.
Subpotent Drug: Subpotent atorvastatin.
Subpotent Drug: Subpotent atorvastatin.
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.
Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.
Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and…
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and…
This page summarizes recall records in which the official source identifies Dr. Reddy's Laboratories, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.