HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial recall — FDA D-1167-2017
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Complete FDA and NHTSA recall records dated in September 2017.
These records include useful source details for the selected month.
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Failed Dissolution Specifications
Failed Dissolution Specifications
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to…
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to…
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to…
After the firm received a consumer complaint, Tomanetti Food Products initiated a recall due to small pieces of flexible plastic found in 12-in. pizza shells.
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to…
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to…
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to…
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to…
Internal label verification found that the breading ingredients for the fish patty were not on the ingredient statement and that wheat not listed as an ingredient or allergen. It also did…
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to…
Product was distributed without going through the retort step.
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to…
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to…
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.