GMP | 2020 U.S. market injection recall inventory

The U.S. pharmaceutical market has always been a global market leader, not only because of the large U.S. market, leading the global drug innovation and research and development, but also because the U.S. drug regulatory system is relatively sound, in all aspects for national pharmaceutical regulatory agencies to provide reference and reference.
cGMP, which was born in the United States in 1962, is the world's first GMP.
, in order to protect the safety of patients, for enterprises to release drugs on the market, clearly stipulated that when defects are found to be recalled in a timely manner.
In the field of product recall, the United States is the world's first country to create a product recall system, from the earliest 1966 U.S. Congress passed the National Transportation and Motor Vehicle Safety Act, the formulation and implementation of a series of regulations on auto product safety recall, and then the recall system has been gradually extended to many products related to human health.
The U.S. definition of recall as a company's withdrawal or correction of defective products sold on the market is based on three main types: voluntary corporate recalls, FDA-required recalls, and mandatory recalls.
Part 7(C) of Chapter 21 of the U.S. Federal Regulations (CFR) provides general guidance for voluntary recalls of products.
addition, the FDA's technical guidelines issued on November 3, 2003, "Product Recall Guidelines (including Withdrawal and Corrections) "Product Recalls, Including Removals and Corrections" cover more specific recommendations and apply to voluntary and mandatory recalls of all FDA regulated products.
, according to data published on the FDA's official website, according to incomplete statistics, the FDA will recall 110 drugs and 18 medical devices in 2020.
, we're focusing on summarizing and analyzing injection recalls for 2020.
A total of 16 injection recalls, all voluntary, were announced on the FDA's official website in 2020, resulting in cross-contamination, product confusion, improper use of preservatives, discovery of particulate matter, polymer polymer over-standards, impurities exceeding standards, empty or possible glass bottle ruptures, mislabeling, ampoule bottle ruptures, precipitation and lack of sterile guarantees leading to recalls of all sterile products (see Table 1).
Table 1 - 2020 FDA Injection Product Recall Typical Case Study: Case 1 - Product Recalls due to Cross-Contamination There are three recalls for 2020 by Fresenius Kabi, of which the July 22 and November 19 product recalls are due to the same reason that the injectable product (lidomyding hydrochloric acid) was contaminated with another active ingredient (Lidokain).
the company was warned by china's drug regulator at the end of 2019 and led to a recall of a product sold in the Chinese market.
case 2 - There are two recalls for mylan in 2020 due to product packaging confusion, including an August recall due to confusion between celine bottles with injections of amino acid and hydrochloride iodide in small boxes.
similar recall occurred on March 24th, when Fagron Sterile Services' product was recalled because of a mislabeling of Thess's pre-filled injection of methyl sulfate.
case 3 - Recalls due to the discovery of particulate matter There will be five recalls due to particulate matter in 2020, including a recall of Fresenius Kabi's ketone glutamate triamcinol injections and mylan's recall of injections of datomycin.
If the intravenous agent contains a solution of visible particles, it may cause serious adverse events, including but not limited to local irritation, vasculitis/venous inflammation, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism.
such a serious defect, indicating that the companies that produce these drugs are clearly flawed in both hardware and software;
4 - Recall of SCA Pharmaceuticals product recall due to improper use of preservatives August 2020 due to the non-declared containing of the preservative phenyl methanol in its heparin sodium products.
the product label lists preservatives as parabens and parabens and do not contain the preservative benzoyl alcohol.
, however, the reality is that the preservative benzool present in these batches does not match the label.
the problem was discovered by SCA Pharmaceuticals during an investigation into low product content bias.
analysis of this case, we can speculate that this deviation should be related to poor cleaning operation between different types of products.
Case 5 - Recall due to over-standard results The recall of Sagent Pharmaceuticals' sodium sephate injection on April 13, 2020 was due to an excess of impurities, and the April 20 recall of cephalosporine and glucose injections from Braun Medical Inc. was due to a high molecular polymer exceeding the standard.
this case is a warning to pharmaceutical industry practitioners that these products are likely to use poor APIs or that undesirable raw materials are incompatible.
Case 6 - Recall of all products due to lack of sterile guarantees January 2020 FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutcal's recall is a large-scale sterile product recall due to problems with the company's sterile assurance levels.
this case contains a lot of products, so this article is not detailed.
the number of varieties and batches covered by the recalled product, it can be speculated that the company's quality control system is basically out of control, leading to such a large area of malignant events.
also shows how difficult it is for the U.S. government's desire to direct some industries back to the U.S.
Case 7 - A company product recall led to a chain recall of other company products April 2020 QuVa Pharma, Inc. recalled the compound pre-filled injection product R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) is a chain reaction caused by a recall of particulate matter in Fresenius Kabi's ketone-corglutinol injection.
because the product is a composite product, ketorolac (ketone glutamate glycol) was prepared by Fresenius Kabi.
this case is more interesting, can be described as the ancient Chinese saying cloud: the city gate fire, the pond fish.
this case shows that when MAH chooses a trusted producer, it is possible to evaluate it comprehensively and avoid choosing a pig teammate.
from the specific information and related analysis of these cases, it can be seen that the advantages of the U.S. pharmaceutical industry in commercial operations and innovative drug research and development.
in traditional pharmaceutical manufacturing, the strengths of the U.S. pharmaceutical industry are not obvious.
with the implementation of China's newly revised Drug Administration Law and the revision of China's drug recall management measures, Chinese pharmaceutical companies are also facing very high compliance pressure.
Chinese companies will combine these cases to fully assess their product and management deficiencies, continuously improve quality and compliance levels, and ensure operational safety.
: This article does not constitute any investment judgment and reference.
reference 1-FDA official website information.