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.
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies…
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
FAILED DISSOLUTION SPECIFICATIONS
FAILED DISSOLUTION SPECIFICATIONS
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed dissolution specifications
Failed dissolution specifications
Failed dissolution specifications
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.
